A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A/H7N9 Inactivated Influenza Vaccines Administered Intramuscularly With or Without AS03 Adjuvant in Healthy Adults 19-50 Years of Age
Overview
- Phase
- Phase 2
- Intervention
- A/H7N9
- Conditions
- Avian Influenza
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 180
- Locations
- 6
- Primary Endpoint
- Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines administered intramuscularly at different dosages, given with or without AS03 adjuvant, using different vaccination schedules. This trial will enroll up to 180 males and non-pregnant females, 19 to 50 years of age, who are in good health and who are influenza A/H7 naïve. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) to evaluate the interval between the first and second doses and the presence of the adjuvant in the first and second doses. The neuraminidase-specific antibody response and the neuraminidase content of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently under development. Study duration is approximately 22 months with subject participation duration of approximately 18 months. The primary objectives of the study are: 1) to assess the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second study vaccine.
Detailed Description
This is a Phase II trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines (2013 and 2017 A/H7N9 IIVs) administered intramuscularly at different dosages (3.75 or 15 mcg of hemagglutinin (HA) per dose), given with or without AS03 adjuvant, using different heterologous and homologous prime-boost vaccination schedules. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. This trial will enroll up to 180 males and non-pregnant females, 19 to 50 years of age, inclusive, who are in good health and meet all eligibility criteria and who are influenza A/H7 vaccine/infection naïve by medical history. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) evaluating the interval between the priming (first) and boosting (second) doses and the presence of the adjuvant in the priming (first) and boosting (second) doses. The neuraminidase-specific antibody response and the neuraminidase content of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently under development. Study duration is approximately 22 months with subject participation duration of approximately 18 months. The primary objectives of the study are: 1) to assess the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second study vaccine. The secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of each study vaccine; 2) to assess medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs), following receipt of each study vaccine; 3) to assess the kinetics and durability of serum HAI and Neut antibody responses following receipt of each study vaccine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide written informed consent prior to initiation of any study procedures.
- •Are able to understand and comply with planned study procedures and be available for all study visits.
- •Must agree to the collection of venous blood per protocol.
- •Must agree to have residual specimens and samples/specimens collected during this trial specifically for the purpose of future research stored for future research use.
- •Are males or non-pregnant females, 19 to 50 years of age, inclusive.
- •Are in good health.
- •As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, Emergency Room (ER), or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.
- •Oral temperature is less than 100.0 degrees Fahrenheit.
- •Pulse is 47 to 100 beats per minute, inclusive.
- •Systolic blood pressure is 85 to 150 mmHg, inclusive.
Exclusion Criteria
- •Have an acute illness, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination.
- •An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
- •Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation.
- •Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
- •Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
- •Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
- •Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
- •Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
- •Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
- •Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
Arms & Interventions
Heterologous Arm 1
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. N=30
Intervention: A/H7N9
Heterologous Arm 1
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. N=30
Intervention: AS03
Heterologous Arm 1
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. N=30
Intervention: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Heterologous Arm 1
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. N=30
Intervention: Phosphate Buffered Saline (PBS) diluent
Heterologous Arm 3
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: AS03
Heterologous Arm 2
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: A/H7N9
Heterologous Arm 2
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: AS03
Heterologous Arm 2
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Heterologous Arm 2
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: Phosphate Buffered Saline (PBS) diluent
Heterologous Arm 3
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: A/H7N9
Heterologous Arm 3
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Heterologous Arm 3
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: Phosphate Buffered Saline (PBS) diluent
Homologous Arm 1
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: A/H7N9
Homologous Arm 1
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: AS03
Homologous Arm 1
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: Phosphate Buffered Saline (PBS) diluent
Homologous Arm 2
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: A/H7N9
Homologous Arm 2
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: AS03
Homologous Arm 2
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: Phosphate Buffered Saline (PBS) diluent
Homologous Arm 3
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: A/H7N9
Homologous Arm 3
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: AS03
Homologous Arm 3
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages. N=30
Intervention: Phosphate Buffered Saline (PBS) diluent
Outcomes
Primary Outcomes
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 142
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 142).
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 43
Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 43
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121
Time Frame: Day 142
Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142).
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 387 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 1 through Day 387
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation; or a congenital anomaly/birth defect.
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 1 through Day 486
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation; or a congenital anomaly/birth defect.
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
Time Frame: Day 1 through Day 8
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 121 through Day 128
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 22 through Day 29
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8
Time Frame: Day 1 through Day 8
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 121 through Day 128
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 22 through Day 29
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8
Time Frame: Day 1 through Day 8
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121
Time Frame: Day 121 through Day 128
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 22 through Day 29
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 43
Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 142
Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142 ).
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22
Time Frame: Day 43
Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 142
Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142).
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 43
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43.
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 142
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142.
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Time Frame: Day 43
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43.
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Time Frame: Day 142
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142.
Secondary Outcomes
- Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1(Day 1)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121(Day 121)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121(Day 301)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22(Day 22)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22(Day 202)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121(Day 121)
- Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22(Day 22)
- Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22(Day 202)
- Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121.(Day 121)
- Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121(Day 301)
- Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1(Day 1)
- Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22(Day 22)
- Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22(Day 202)
- Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121(Day 121)
- Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121(Day 301)
- Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)(Day 1 through Day 387)
- Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)(Day 1 through Day 486)
- Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22(Day 1 through Day 22)
- Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 22 Through Day 43 in Participants Who Received Their Second Study Vaccination on Day 22(Day 22 through Day 43)
- Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121(Day 121 through Day 142)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22(Day 22)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22(Day 202)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121(Day 301)
- Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1(Day 1)
- Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22(Day 22)
- Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22(Day 202)
- Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121(Day 121)
- Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121(Day 301)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1(Day 1)
- Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22(Day 22)
- Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22(Day 202)
- Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121(Day 121)
- Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121(Day 301)