An Exploratory, Retrospective Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 HA Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GSK Biologicals' Pandemic Influenza Vaccines

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort

时间窗: At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 Cohort

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 21 (post-vaccination 1 compared to pre-vaccination), Day 42 (post-vaccination 2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. Seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

With respect to samples from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by microneutralization (MN) for all subjects who received an adjuvant system (AS) vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution (1/DIL).

Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.

Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182); at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

时间窗: At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥10-fold increases were only calculated relative to baseline.

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

时间窗: At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines

时间窗: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (post-vaccination2 compared to Day 0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385[post-vaccination2]/ Day 0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort

时间窗: At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

时间窗: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort

时间窗: At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort

时间窗: At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

时间窗: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

时间窗: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

时间窗: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (post-vaccination2 compared to Day 0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort

时间窗: At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385(post-vaccination2/ Day 0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution )

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution).

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines

时间窗: At Day 42 (post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution ).

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2 compared to pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

时间窗: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

时间窗: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

时间窗: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

时间窗: At Day 42 (post-vaccination2/ pre-vaccination)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1 compared to [/]D0)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

时间窗: At D21 (post-dose1) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort

时间窗: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

时间窗: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

时间窗: At D0 (Pre), D21 (Post-dose 1)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL