Avian Influenza, Influenza, Influenza Immunisation
Conditions
Keywords
AS03-adjuvanted Inactivated Influenza Vaccine, Co-Administered, Healthy Adults, Immunogenicity, Inactivated Seasonal Influenza Vaccine, Phase II, Safety
Brief summary
This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This study is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups. The study will enroll approximately 150 individuals who have no history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months with subject participation duration of approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following sequential or simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza strains at approximately 21 days following receipt of IIV4.
Detailed description
This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vaccine (2017 H7N9 IIV) manufactured by Sanofi Pasteur (3.75 mcg of HA per dose with Phosphate Buffered Saline (PBS) diluent), when two doses are administered 21 days apart either sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups. Group 1 will receive two doses of AS03-adjuvanted 2017 H7N9 IIV, each dose administered IM approximately 21 days apart, and one dose of licensed seasonal IIV4 will be administered IM simultaneously (within 15 minutes) with the first dose of AS03 adjuvanted 2017 H7N9 IIV. Group 2 will receive one dose of IIV4 approximately 21 days prior to the IM administration of two doses of AS03-adjuvanted 2017 H7N9 IIV; each dose of AS03-adjuvanted 2017 H7N9 IIV will be given approximately 21 days apart. Group 3 will receive one dose IM of IIV4 as an un-blinded comparator. The study will enroll approximately 150 individuals who have no history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months with subject participation duration of approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following sequential or simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza strains at approximately 21 days following receipt of IIV4. The secondary objectives are: 1) to assess unsolicited non-SAEs following sequential or simultaneous IM administration of AS03-adjuvanted 2017 H7N9 IIV and seasonal influenza vaccine (IIV4); 2) to assess MAAEs, including NOCMCs and PIMMCs, following sequential or simultaneous IM administration of AS03-adjuvanted 2017 H7N9 IIV and IIV4; 3) to assess the HAI and Neut antibody responses at 21 days following receipt of 1 dose of AS03-adjuvanted 2017 H7N9 IIV.
Interventions
DRUGAS03
AS03 oil-in-water emulsion adjuvant.
BIOLOGICALInactivated influenza H7N9 vaccine
Monovalent 2017 H7N9 inactivated influenza vaccine
A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N2) and 2 influenza B subtypes (B Yamata lineage and B Victoria lineage).
Diluent for Adjuvanted 2017 Monovalent Inactivated Influenza A/H7N9 vaccine (2017 H7N9IIV)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females, 19 -64 years of age, inclusive. 4. 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. 5. Oral temperature is less than 100.0°F. 6. Pulse is 47 to 100 beats per minute (bpm), inclusive. 7. Systolic blood pressure is 85 to 150 mmHg, inclusive (subjects \<65 years of age), 85 to 160 mmHg, inclusive (subjects = / \> 65 years of age). 8. Diastolic blood pressure is 55 to 95 mmHg, inclusive. 9. ESR is less than 30 mm per hour. 10. Women of childbearing potential must use an acceptable contraception method from 30 days before first study vaccination until 60 days after last study vaccination. \- Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year of the last menses if menopausal. \-- Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives (the pill). 11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 21 days after second dose of H7N9 | Blood was collected for the serum neutralizing antibody 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. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2 |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Day 1 up to Day 408 | 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. All events are included regardless of relationship to the study product. |
| Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | 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 Assessed With Clinical Safety Laboratory AEs After Second Vaccination | 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 Assessed With Clinical Safety Laboratory AEs After Third Vaccination | Day 50 | 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 AEs After First Vaccination | Day 1 up to day 8 | Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination 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 (measurement grade) |
| Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Day 1 up to 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 following vaccination. |
| Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Day 22 up to day 29 | Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination 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 (measurement grade) |
| Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Day 43 up to day 50 | Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination 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 (measurement grade) |
| Occurrence of Study Vaccine-related SAEs | Day 1 up to day 408 | 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. Events are included if deemed by the investigator to be related to the study product. |
| Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Day 22 up to 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 following vaccination. |
| Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Day 43 up to day 50 | 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 following vaccination. |
| Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 21 days after second dose of H7N9 | 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 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2. |
| Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 21 days after second dose of H7N9 | Blood was collected for the serum neutralizing antibody 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 neutralizing antibody pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2. |
| Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | Day 22 | Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. 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 or greater and min. 4-fold rise in post-vaccination antibody titer. |
| Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | Day 22 | Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. 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. |
| Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 21 days after second dose of H7N9 | 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. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2 |
| Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | Day 22 | Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. 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. |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination | 21 days after second dose of H7N9 | Blood was collected for HAI assay at 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 from the available results at 21 days after the second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2. |
| GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | Day 22 | Blood was collected for HAI assay at conducted with the IIV4 vaccine viruses as the antigens. 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. |
| GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | Day 22 | Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. 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. |
| GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination | 21 days after second dose of H7N9 | Blood was collected for the serum neutralizing antibody 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 geometric mean titer was calculated for each study arm from the available results at 21 days after second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 21 days after first dose of H7N9 | Blood was collected for HAI assay at 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. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2. |
| GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | Day 1 | Blood was collected for the serum neutralizing antibody assay at 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. |
| GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 21 days after first dose of H7N9 | Blood was collected for serum neutralizing antibody assay at 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. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2. |
| Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Approximately 21 days after first vaccination | Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Approximately 21 days after second vaccination | Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination | Approximately 21 days after third vaccination | Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Day 1 up to day 408 | Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study. |
| Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Approximately 21 days after first vaccination | Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Approximately 21 days after second vaccination | Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination | Approximately 21 days after third vaccination | Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 21 days after first dose of H7N9 | Blood was collected for HAI assay at 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. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2. |
| Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 21 days after first dose of H7N9 | Blood was collected for serum neutralizing antibody assay at 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. Seroconversion was defined as a pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2. |
| Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | Day 1 | Blood was collected for HAI assay at 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. |
| Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 21 days after first dose of H7N9 | Blood was collected for serum neutralizing antibody assay at 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. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2 |
| Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | Day 1 | Blood was collected for serum neutralizing antibody assay at 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. |
| Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 21 days after first dose of H7N9 | Blood was collected for serum neutralizing antibody assay at 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. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2 |
| GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | Day 1 | Blood was collected for HAI assay at 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. |
Countries
United States
Participant flow
Recruitment details
Healthy adult participants 19-64 years of age were recruited from the communities surrounding each clinical site, and were enrolled between 20FEB2018 and 29JUN2018.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Simultaneous Administration 3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 | 62 |
| Group 2 Sequential Administration 0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43 | 53 |
| Group 3 IIV4 Only 0.5 ml dose of IIV4 vaccine IM on Day 1, n=30 | 34 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 53 Participants | 34 Participants | 149 Participants |
| Age, Continuous | 39.1 years STANDARD_DEVIATION 13.1 | 38.1 years STANDARD_DEVIATION 11.5 | 35.7 years STANDARD_DEVIATION 10.6 | 38.0 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 60 Participants | 52 Participants | 31 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 29 Participants | 17 Participants | 82 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 17 Participants | 14 Participants | 53 Participants |
| Region of Enrollment United States | 62 participants | 53 participants | 34 participants | 149 participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 13 Participants | 65 Participants |
| Sex: Female, Male Male | 36 Participants | 27 Participants | 21 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 53 | 0 / 34 |
| other Total, other adverse events | 57 / 62 | 48 / 53 | 25 / 34 |
| serious Total, serious adverse events | 0 / 62 | 1 / 53 | 0 / 34 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination
Blood was collected for HAI assay at 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 from the available results at 21 days after the second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
Time frame: 21 days after second dose of H7N9
Population: Participants included in the modified intent-to-treat (mITT) population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Simultaneous Administration | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination | 36.8 titer |
| Group 2 Sequential Administration | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination | 22.7 titer |
Primary
GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains
Blood was collected for HAI assay at conducted with the IIV4 vaccine viruses as the antigens. 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.
Time frame: Day 22
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 Simultaneous Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 547.7 titer |
| Group 1 Simultaneous Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 284.0 titer |
| Group 1 Simultaneous Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 20.8 titer |
| Group 1 Simultaneous Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 46.1 titer |
| Group 2 Sequential Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 61.8 titer |
| Group 2 Sequential Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 503.6 titer |
| Group 2 Sequential Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 23.05 titer |
| Group 2 Sequential Administration | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 289.8 titer |
| Group 3 IIV4 Only | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 64.1 titer |
| Group 3 IIV4 Only | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 462.6 titer |
| Group 3 IIV4 Only | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 44.4 titer |
| Group 3 IIV4 Only | GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 480.4 titer |
Primary
GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. 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.
Time frame: Day 22
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 Simultaneous Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 230.4 titer |
| Group 1 Simultaneous Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 481.3 titer |
| Group 1 Simultaneous Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 237.9 titer |
| Group 1 Simultaneous Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 118.9 titer |
| Group 2 Sequential Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 157.4 titer |
| Group 2 Sequential Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 186.0 titer |
| Group 2 Sequential Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 251.5 titer |
| Group 2 Sequential Administration | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 518.4 titer |
| Group 3 IIV4 Only | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 202.0 titer |
| Group 3 IIV4 Only | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 788.9 titer |
| Group 3 IIV4 Only | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 452.5 titer |
| Group 3 IIV4 Only | GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 227.6 titer |
Primary
GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination
Blood was collected for the serum neutralizing antibody 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 geometric mean titer was calculated for each study arm from the available results at 21 days after second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
Time frame: 21 days after second dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Simultaneous Administration | GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination | 88.4 titer |
| Group 2 Sequential Administration | GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination | 50.5 titer |
Primary
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
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.
Time frame: Day 8
Population: The safety population includes all subject receiving study product with data at the time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | platelets | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | creatinine | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | hemoglobin | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | WBC | 5 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | bilirubin | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | ALT | 3 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | creatinine | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | ALT | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | bilirubin | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | hemoglobin | 6 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | platelets | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | WBC | 4 Participants |
| Group 3 IIV4 Only | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | bilirubin | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | WBC | 2 Participants |
| Group 3 IIV4 Only | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | platelets | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | creatinine | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | ALT | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination | hemoglobin | 3 Participants |
Primary
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
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.
Time frame: Day 29
Population: The safety population includes all subject receiving study product with data at the time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | creatinine | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | hemoglobin | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | platelets | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | WBC | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | ALT | 5 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | bilirubin | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | WBC | 6 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | creatinine | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | bilirubin | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | hemoglobin | 4 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | ALT | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination | platelets | 0 Participants |
Primary
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
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.
Time frame: Day 50
Population: The safety population includes all subject receiving study product with data at the time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination | ALT | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination | bilirubin | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination | creatinine | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination | hemoglobin | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination | platelets | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination | WBC | 5 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
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. All events are included regardless of relationship to the study product.
Time frame: Day 1 up to Day 408
Population: The safety population includes all subjects receiving study product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination 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 (measurement grade)
Time frame: Day 1 up to day 8
Population: The safety population includes all subject receiving study product with data reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Ecchymosis/Bruising (functional grade) | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Pain | 44 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Erythema/Redness (measured) | 14 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Ecchymosis/Bruising (measured) | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Induration/Swelling (measured) | 11 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Erythema/Redness (functional grade) | 15 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Itching/Pruritus | 5 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Tenderness | 44 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Induration/Swelling (functional grade) | 13 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Induration/Swelling (measured) | 5 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Pain | 18 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Tenderness | 30 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Itching/Pruritus | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Ecchymosis/Bruising (functional grade) | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Ecchymosis/Bruising (measured) | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Erythema/Redness (functional grade) | 5 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Erythema/Redness (measured) | 5 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Induration/Swelling (functional grade) | 5 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Ecchymosis/Bruising (functional grade) | 1 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Induration/Swelling (measured) | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Erythema/Redness (measured) | 4 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Itching/Pruritus | 2 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Pain | 14 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Induration/Swelling (functional grade) | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Ecchymosis/Bruising (measured) | 1 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Tenderness | 17 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Injection Site AEs After First Vaccination | Erythema/Redness (functional grade) | 4 Participants |
Primary
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination 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 (measurement grade)
Time frame: Day 22 up to day 29
Population: The safety population includes all subject receiving study product with data reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Tenderness | 32 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Pain | 24 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Itching/Pruritus | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Ecchymosis/Bruising (functional grade) | 5 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Erythema/Redness (functional grade) | 13 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Erythema/Redness (measured) | 12 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Induration/Swelling (functional grade) | 13 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Induration/Swelling (measured) | 12 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Ecchymosis/Bruising (measured) | 5 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Induration/Swelling (measured) | 9 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Erythema/Redness (functional grade) | 7 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Pain | 24 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Tenderness | 32 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Induration/Swelling (functional grade) | 9 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Itching/Pruritus | 3 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Erythema/Redness (measured) | 7 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Ecchymosis/Bruising (functional grade) | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination | Ecchymosis/Bruising (measured) | 2 Participants |
Primary
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination 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 (measurement grade)
Time frame: Day 43 up to day 50
Population: The safety population includes all subject receiving study product with data reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Pain | 17 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Tenderness | 30 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Itching/Pruritus | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Ecchymosis/Bruising (functional grade) | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Ecchymosis/Bruising (measured) | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Erythema/Redness (functional grade) | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Erythema/Redness (measured) | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Induration/Swelling (functional grade) | 5 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination | Induration/Swelling (measured) | 5 Participants |
Primary
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
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 following vaccination.
Time frame: Day 1 up to day 8
Population: The safety population includes all participants receiving the dose and for whom solicited data were reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Malaise | 19 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Nausea | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Arthralgia | 8 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Myalgia | 28 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Elevated Oral Temperature | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Fatigue | 25 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Feverishness | 13 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Headache | 17 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Myalgia | 7 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Elevated Oral Temperature | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Feverishness | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Fatigue | 11 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Malaise | 6 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Arthralgia | 4 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Headache | 7 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Nausea | 1 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Arthralgia | 4 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Fatigue | 7 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Nausea | 5 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Headache | 8 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Feverishness | 3 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Myalgia | 9 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Malaise | 8 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Solicited Systemic AEs After First Vaccination | Elevated Oral Temperature | 2 Participants |
Primary
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
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 following vaccination.
Time frame: Day 43 up to day 50
Population: The safety population includes all participants receiving the dose and for whom solicited data were reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Elevated Oral Temperature | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Feverishness | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Fatigue | 10 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Myalgia | 11 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Arthralgia | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Headache | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Nausea | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Solicited Systemic AEs After Third Vaccination | Malaise | 5 Participants |
Primary
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
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 following vaccination.
Time frame: Day 22 up to day 29
Population: The safety population includes all participants receiving the dose and for whom solicited data were reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Elevated Oral Temperature | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Feverishness | 8 Participants |
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Fatigue | 17 Participants |
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Malaise | 13 Participants |
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Myalgia | 19 Participants |
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Arthralgia | 9 Participants |
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Headache | 13 Participants |
| Group 1 Simultaneous Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Nausea | 6 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Nausea | 6 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Elevated Oral Temperature | 1 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Myalgia | 8 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Feverishness | 7 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Headache | 8 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Fatigue | 14 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Arthralgia | 5 Participants |
| Group 2 Sequential Administration | Number of Participating Reporting Solicited Systemic AEs After Second Vaccination | Malaise | 9 Participants |
Primary
Occurrence of Study Vaccine-related SAEs
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. Events are included if deemed by the investigator to be related to the study product.
Time frame: Day 1 up to day 408
Population: The safety population includes all subjects receiving study product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Simultaneous Administration | Occurrence of Study Vaccine-related SAEs | 0 Participants |
| Group 2 Sequential Administration | Occurrence of Study Vaccine-related SAEs | 0 Participants |
| Group 3 IIV4 Only | Occurrence of Study Vaccine-related SAEs | 0 Participants |
Primary
Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
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 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after second dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 51 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 38 percentage of participants |
Primary
Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. 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 or greater and min. 4-fold rise in post-vaccination antibody titer.
Time frame: Day 22
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 53 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 49 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 19 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 29 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 47 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 58 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 13 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 55 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 48 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 72 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 41 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 55 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
Blood was collected for the serum neutralizing antibody 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 neutralizing antibody pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after second dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 82 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 74 percentage of participants |
Primary
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. 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.
Time frame: Day 22
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 100 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 93 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 25 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 54 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 72 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 96 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 30 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 94 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 76 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 100 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 62 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 93 percentage of participants |
Primary
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
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. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
Time frame: 21 days after second dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 51 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 38 percentage of participants |
Primary
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. 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.
Time frame: Day 22
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 98 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 93 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 95 percentage of participants |
| Group 1 Simultaneous Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 90 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 96 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 85 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 100 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 94 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Brisbane/60/2008 (B Victoria lineage) | 100 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Hong Kong/4801/2014 X-263B (H3N2) | 100 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 100 percentage of participants |
| Group 3 IIV4 Only | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains | A/Michigan/45/2015 x-275 (H1N1) | 93 percentage of participants |
Primary
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
Blood was collected for the serum neutralizing antibody 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. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
Time frame: 21 days after second dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 84 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 74 percentage of participants |
Secondary
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
Blood was collected for HAI assay at 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. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Simultaneous Administration | GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 9.9 titer |
| Group 2 Sequential Administration | GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 6.6 titer |
Secondary
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
Blood was collected for HAI assay at 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.
Time frame: Day 1
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Simultaneous Administration | GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | 5.7 titer |
| Group 2 Sequential Administration | GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | 5.7 titer |
Secondary
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at 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. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Simultaneous Administration | GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 22.3 titer |
| Group 2 Sequential Administration | GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 18.4 titer |
Secondary
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
Blood was collected for the serum neutralizing antibody assay at 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.
Time frame: Day 1
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Simultaneous Administration | GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | 5.9 titer |
| Group 2 Sequential Administration | GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | 5.4 titer |
Secondary
Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study.
Time frame: Day 1 up to day 408
Population: The safety population included all participants who received at least one dose of study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 6 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 6 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 2 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
Secondary
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after first vaccination
Population: The safety population includes all participants receiving the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Any SOC | 7 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Gastrointestinal Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | General Disorders / Administration Site Conditions | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Infections And Infestations | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Investigations | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Nervous System Disorders | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Psychiatric Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Respiratory, Thoracic And Mediastinal Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | General Disorders / Administration Site Conditions | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Psychiatric Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Infections And Infestations | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Investigations | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Nervous System Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Any SOC | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Gastrointestinal Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Respiratory, Thoracic And Mediastinal Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Nervous System Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Gastrointestinal Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Any SOC | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Infections And Infestations | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Psychiatric Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | General Disorders / Administration Site Conditions | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Investigations | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination | Respiratory, Thoracic And Mediastinal Disorders | 0 Participants |
Secondary
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after second vaccination
Population: The safety population includes all participants receiving the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Any SOC | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Gastrointestinal Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | General Disorders / Administration Site Conditions | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Infections And Infestations | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Nervous System Disorders | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Musculoskeletal And Connective Tissue Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Nervous System Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Any SOC | 3 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Infections And Infestations | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Gastrointestinal Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | Musculoskeletal And Connective Tissue Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination | General Disorders / Administration Site Conditions | 0 Participants |
Secondary
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after third vaccination
Population: The safety population includes all participants receiving the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination | Any SOC | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination | Investigations | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination | Nervous System Disorders | 1 Participants |
Secondary
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after first vaccination
Population: The safety population includes all participants receiving the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Psychiatric Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Infections And Infestations | 8 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Eye Disorders | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Nervous System Disorders | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Injury, Poisoning And Procedural Complications | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Blood And Lymphatic System Disorders | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Musculoskeletal And Connective Tissue Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Investigations | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Respiratory, Thoracic And Mediastinal Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Gastrointestinal Disorders | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Any SOC | 18 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Reproductive System And Breast Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | General Disorders / Administration Site Conditions | 3 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Vascular Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Nervous System Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Any SOC | 11 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Blood And Lymphatic System Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Eye Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Gastrointestinal Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | General Disorders / Administration Site Conditions | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Infections And Infestations | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Injury, Poisoning And Procedural Complications | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Investigations | 3 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Musculoskeletal And Connective Tissue Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Psychiatric Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Reproductive System And Breast Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Respiratory, Thoracic And Mediastinal Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Vascular Disorders | 1 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Nervous System Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | General Disorders / Administration Site Conditions | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Blood And Lymphatic System Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Psychiatric Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Gastrointestinal Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Any SOC | 4 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Reproductive System And Breast Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Eye Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Vascular Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Investigations | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Injury, Poisoning And Procedural Complications | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Respiratory, Thoracic And Mediastinal Disorders | 0 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Musculoskeletal And Connective Tissue Disorders | 1 Participants |
| Group 3 IIV4 Only | Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination | Infections And Infestations | 3 Participants |
Secondary
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after second vaccination
Population: The safety population includes all participants who received the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Gastrointestinal Disorders | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Investigations | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Infections And Infestations | 5 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Musculoskeletal And Connective Tissue Disorders | 2 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | General Disorders / Administration Site Conditions | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Nervous System Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Injury, Poisoning And Procedural Complications | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Psychiatric Disorders | 0 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Any SOC | 12 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Psychiatric Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Any SOC | 6 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Gastrointestinal Disorders | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | General Disorders / Administration Site Conditions | 1 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Infections And Infestations | 2 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Injury, Poisoning And Procedural Complications | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Investigations | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Musculoskeletal And Connective Tissue Disorders | 0 Participants |
| Group 2 Sequential Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination | Nervous System Disorders | 1 Participants |
Secondary
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after third vaccination
Population: The safety population includes all participants who received the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination | Any SOC | 4 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination | General Disorders / Administration Site Conditions | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination | Investigations | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination | Musculoskeletal And Connective Tissue Disorders | 1 Participants |
| Group 1 Simultaneous Administration | Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination | Nervous System Disorders | 1 Participants |
Secondary
Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for HAI assay at 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. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 14 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at 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. Seroconversion was defined as a pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 34 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 28 percentage of participants |
Secondary
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at 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. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
Time frame: 21 days after first dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 14 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
Blood was collected for HAI assay at 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.
Time frame: Day 1
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | 0 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | 0 percentage of participants |
Secondary
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at 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. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
Time frame: 21 days after first dose of H7N9
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 34 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 28 percentage of participants |
Secondary
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
Blood was collected for serum neutralizing antibody assay at 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.
Time frame: Day 1
Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Simultaneous Administration | Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | 2 percentage of participants |
| Group 2 Sequential Administration | Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | 0 percentage of participants |