A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Dose of 2017 A/H7N9 Inactivated Influenza Vaccine (IIV) Administered Intramuscularly With or Without AS03 Adjuvant in 2013 A/H7N9 IIV Primed or A/H7 IIV Naïve Subjects
Overview
- Phase
- Phase 2
- Intervention
- A/H7N9
- Conditions
- Avian Influenza
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 304
- Locations
- 9
- Primary Endpoint
- Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.
Detailed Description
This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria, which include a screening erythrocyte sedimentation rate (ESR) laboratory evaluation. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV) manufactured by Sanofi Pasteur (SP), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant manufactured by GlaxoSmithKline Biologicals (GSK), to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC will be used to achieve the targeted dosage. Subjects who received the 2013 A/H7N9 IIV in DMID Protocols 13-0032 and 13-0033 or are A/H7 IIV-naïve will be stratified by prior receipt of 2013 A/H7N9 IIV, as well as by site and prior receipt of licensed, seasonal influenza vaccine (defined as receipt of at least one of the 2017-2018 and/or 2018-2019 licensed, seasonal influenza vaccines versus none), then randomly assigned in a 1:1 ratio to 1 of 2 treatment arms to receive 1 dose of 2017 A/H7N9 IIV at 3.75 mcg HA per dose with or without AS03 adjuvant. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine. Secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of the 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 the study vaccine; 3) To assess the kinetics and durability of serum HAI and Neut antibody responses following receipt of the study vaccine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects eligible to participate in this trial must meet all of the following 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 70 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 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 PI 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 PI 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 (except inhaled corticosteroids as outlined in the Subject Exclusion Criteria as well as 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
- •Subjects eligible to participate in this trial must not meet any of the following exclusion criteria:
- •Have an acute illness\*, as determined by the site PI 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 PI 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 PI 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 cytotoxic anticancer chemotherapy or radiation therapy 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.
Arms & Interventions
Arm 1
Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: A/H7N9
Arm 1
Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: AS03
Arm 1
Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: Phosphate Buffered Saline (PBS) diluent
Arm 2
Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: A/H7N9
Arm 2
Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: AS03
Arm 3
Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: A/H7N9
Arm 2
Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: Phosphate Buffered Saline (PBS) diluent
Arm 3
Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: AS03
Arm 3
Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: Phosphate Buffered Saline (PBS) diluent
Arm 4
Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: A/H7N9
Arm 4
Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: AS03
Arm 4
Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: Phosphate Buffered Saline (PBS) diluent
Arm 5
Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: A/H7N9
Arm 5
Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: AS03
Arm 5
Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
Intervention: Phosphate Buffered Saline (PBS) diluent
Outcomes
Primary Outcomes
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
Time Frame: Day 1 to 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.
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Time Frame: Day 22
Blood was collected for HAI assay which was 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. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Time Frame: Day 22
Blood was collected for Neutralizing assay which was 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. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Number of Participants Reporting Serious Adverse Events (SAEs)
Time Frame: Day 1 through Day 366
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 Solicited Injection Site Reactogenicity Events
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 Systemic Reactogenicity Events
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.
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Time Frame: Day 22
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. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Time Frame: Day 22
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. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Time Frame: Day 22
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 study vaccination is Day 22.
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Time Frame: Day 22
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 study vaccination is Day 22.
Secondary Outcomes
- Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus(Day 8)
- Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus(Day 181)
- Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)(Day 22)
- Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)(Day 1 through Day 366)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 181)
- Number of Participants Reporting Unsolicited Non-serious AEs(Day 1 through Day 22)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 8)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 8)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)(Day 22)
- Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 8)
- Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 181)
- Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)(Day 22)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 8)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 181)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)(Day 22)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 8)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 181)
- Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus(Day 181)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)(Day 22)
- Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)(Day 22)