Avian Influenza, Influenza Immunisation
Conditions
Keywords
A/H7N9 Inactivated Influenza Vaccine, AS03 Adjuvant, Immunogenicity, Influenza, Phase II, Reactogenicity, Safety, Vaccine
Brief summary
This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.
Detailed description
This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria, which include a screening erythrocyte sedimentation rate (ESR) laboratory evaluation. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV) manufactured by Sanofi Pasteur (SP), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant manufactured by GlaxoSmithKline Biologicals (GSK), to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC will be used to achieve the targeted dosage. Subjects who received the 2013 A/H7N9 IIV in DMID Protocols 13-0032 and 13-0033 or are A/H7 IIV-naïve will be stratified by prior receipt of 2013 A/H7N9 IIV, as well as by site and prior receipt of licensed, seasonal influenza vaccine (defined as receipt of at least one of the 2017-2018 and/or 2018-2019 licensed, seasonal influenza vaccines versus none), then randomly assigned in a 1:1 ratio to 1 of 2 treatment arms to receive 1 dose of 2017 A/H7N9 IIV at 3.75 mcg HA per dose with or without AS03 adjuvant. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine. Secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of the study vaccine; 2) to assess medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs), following receipt of the study vaccine; 3) To assess the kinetics and durability of serum HAI and Neut antibody responses following receipt of the study vaccine.
Interventions
BIOLOGICALA/H7N9
Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).
DRUGAS03
AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.
0.006M PBS diluent for Influenza Virus Vaccine.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects eligible to participate in this trial must meet all of the following 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. Must agree to the collection of venous blood per protocol. 4. Must agree to have residual specimens and samples/specimens collected during this trial specifically for the purpose of future research stored for future research use. 5. Are males or non-pregnant females, 19 to 70 years of age, inclusive. 6. Are in good health\* \*As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site PI or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal and inhaled medications (except inhaled corticosteroids as outlined in the Subject
Exclusion criteria
as well as herbals, vitamins and supplements are permitted. 7. Oral temperature is less than 100.0 degrees Fahrenheit. 8. Pulse is 47 to 100 beats per minute, inclusive. 9. Systolic blood pressure is 85 to 150 mmHg, inclusive. 10. Diastolic blood pressure is 55 to 95 mmHg, inclusive. 11. Erythrocyte Sedimentation Rate (ESR) is less than 30 mm per hour. 12. Women of childbearing potential\*\* must use an acceptable contraception method\*\*\* from 30 days before study vaccination until 60 days after study vaccination. \*\*Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) 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 has passed since 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 study vaccination, barrier methods such as condoms or diaphragms/cervical cap with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives (the pill). 13. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination. 14. Received 1 or 2 doses of 2013 A/H7N9 IIV with or without AS03 or MF59 adjuvant in DMID Protocols 13-0032 or 13-0033, or are A/H7 IIV-naïve.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 22 | Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22). |
| Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 22 | Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22). |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Day 1 through Day 366 | SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. |
| Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Day 1 to Day 8 | Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher. |
| Number of Participants Reporting Solicited Injection Site Reactogenicity Events | Day 1 through Day 8 | Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination. |
| Number of Participants Reporting Solicited Systemic Reactogenicity Events | Day 1 through Day 8 | Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 22 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22). |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 22 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22). |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | Day 22 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | Day 22 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 181 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 180 days post second vaccination (Day 181). |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 181 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181). |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 8 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days post study vaccination. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 181 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 181 is 180 days post study vaccination. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 8 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 7 days after study vaccination is Day 8. |
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | Day 8 | Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8). |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | Day 22 | Blood was collected for the HAI assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post second vaccination (Day 22). |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | Day 22 | Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22). |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | Day 22 | Blood was collected for the HAI assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days post study vaccination. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | Day 22 | Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 181 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after study vaccination is Day 181. |
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | Day 181 | Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181). |
| Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 8 | Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8). |
| Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 181 | Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181). |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | Day 22 | Blood was collected for HAI assay which was conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22). |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | Day 22 | Blood was collected for Neutralizing assay which was conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22). |
| Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Day 1 through Day 366 | 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 Unsolicited Non-serious AEs | Day 1 through Day 22 | 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 21 days after study vaccination. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 8 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 7 days post second vaccination (Day 8). |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | Day 8 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8). |
Countries
United States
Participant flow
Recruitment details
Participants were healthy males and non-pregnant females between 19 and 70 years old, inclusively. They were recruited from the communities at large around the clinical sites. Participants were enrolled between 18DEC2018 and 19MAR2019.
Participants by arm
| Arm | Count |
|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. | 38 |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. | 40 |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. | 24 |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. | 18 |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. | 40 |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. | 44 |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. | 20 |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. | 16 |
| A/H7 IIV Naïve |2017 A/H7N9 IIV 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. | 29 |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. | 35 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | 2013 A/H7N9 IIV|2017 A/H7N9 IIV | 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | A/H7 IIV Naïve |2017 A/H7N9 IIV | A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Age, Categorical 19 - 35 years | 5 Participants | 4 Participants | 1 Participants | 11 Participants | 5 Participants | 5 Participants | 9 Participants | 4 Participants | 20 Participants | 19 Participants | 83 Participants |
| Age, Customized Age, Categorical 36 - 50 years | 6 Participants | 18 Participants | 6 Participants | 11 Participants | 15 Participants | 3 Participants | 14 Participants | 3 Participants | 3 Participants | 10 Participants | 89 Participants |
| Age, Customized Age, Categorical 51-70 years | 13 Participants | 18 Participants | 11 Participants | 18 Participants | 24 Participants | 12 Participants | 15 Participants | 9 Participants | 6 Participants | 6 Participants | 132 Participants |
| Body Mass Index (BMI) < 30 kg/m^2 | 16 Participants | 26 Participants | 13 Participants | 29 Participants | 28 Participants | 15 Participants | 25 Participants | 8 Participants | 17 Participants | 26 Participants | 203 Participants |
| Body Mass Index (BMI) >= 30 kg/m^2 | 8 Participants | 14 Participants | 5 Participants | 11 Participants | 16 Participants | 5 Participants | 13 Participants | 8 Participants | 12 Participants | 9 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants | 4 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 38 Participants | 18 Participants | 38 Participants | 41 Participants | 20 Participants | 37 Participants | 14 Participants | 25 Participants | 31 Participants | 283 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Prior Seasonal Influenza Vaccination 2017-2018 and 2018-2019 | 17 Participants | 32 Participants | 13 Participants | 31 Participants | 30 Participants | 16 Participants | 30 Participants | 10 Participants | 13 Participants | 14 Participants | 206 Participants |
| Prior Seasonal Influenza Vaccination 2017-2018 only | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 6 Participants | 7 Participants | 26 Participants |
| Prior Seasonal Influenza Vaccination 2018-2019 only | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 6 Participants | 0 Participants | 3 Participants | 3 Participants | 4 Participants | 6 Participants | 28 Participants |
| Prior Seasonal Influenza Vaccination Neither | 4 Participants | 3 Participants | 3 Participants | 5 Participants | 6 Participants | 3 Participants | 5 Participants | 1 Participants | 6 Participants | 8 Participants | 44 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 0 Participants | 6 Participants | 3 Participants | 10 Participants | 11 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 22 Participants | 35 Participants | 13 Participants | 34 Participants | 34 Participants | 18 Participants | 30 Participants | 11 Participants | 12 Participants | 20 Participants | 229 Participants |
| Region of Enrollment United States | 24 participants | 40 participants | 18 participants | 40 participants | 44 participants | 20 participants | 38 participants | 16 participants | 29 participants | 35 participants | 304 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 16 Participants | 26 Participants | 25 Participants | 11 Participants | 18 Participants | 13 Participants | 16 Participants | 15 Participants | 172 Participants |
| Sex: Female, Male Male | 13 Participants | 19 Participants | 2 Participants | 14 Participants | 19 Participants | 9 Participants | 20 Participants | 3 Participants | 13 Participants | 20 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 40 | 0 / 24 | 0 / 18 | 0 / 40 | 0 / 44 | 0 / 20 | 0 / 16 | 0 / 29 | 0 / 35 |
| other Total, other adverse events | 25 / 38 | 37 / 40 | 12 / 24 | 16 / 18 | 29 / 40 | 40 / 44 | 13 / 20 | 15 / 16 | 19 / 29 | 34 / 35 |
| serious Total, serious adverse events | 0 / 38 | 1 / 40 | 0 / 24 | 0 / 18 | 0 / 40 | 0 / 44 | 0 / 20 | 0 / 16 | 1 / 29 | 0 / 35 |
Outcome results
Primary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 22.7 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 116.1 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 77.7 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 190.3 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 10.9 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 31.7 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 33.1 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 180.9 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 6.6 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 8.3 titer |
Primary
Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 64.3 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 367.6 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 204.5 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 870.9 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 28.6 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 72.2 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 115.1 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 562.0 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 5.8 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 10.8 titer |
Primary
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
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 1 to Day 8
Population: The safety population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 were included for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 3 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 2 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 1 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 2 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 2 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 1 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 1 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 1 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 3 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 2 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 1 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 1 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 3 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 2 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 3 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 2 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 3 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 1 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 3 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 1 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | WBC | 3 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Creatinine | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | ALT | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Hemoglobin | 3 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Bilirubin | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) | Platelets | 2 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.
Time frame: Day 1 through Day 366
Population: The safety population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants Reporting Solicited Injection Site Reactogenicity Events
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time frame: Day 1 through Day 8
Population: The safety population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 11 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 35 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 5 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 16 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 11 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 38 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 3 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 14 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 12 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Injection Site Reactogenicity Events | 30 Participants |
Primary
Number of Participants Reporting Solicited Systemic Reactogenicity Events
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time frame: Day 1 through Day 8
Population: The safety population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 12 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 24 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 8 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 6 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 16 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 16 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 7 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 10 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 10 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Solicited Systemic Reactogenicity Events | 20 Participants |
Primary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 49 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 88 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 75 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 83 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 20 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 52 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 55 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 88 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 7 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 6 percentage of participants |
Primary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 49 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 88 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 75 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 89 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 20 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 59 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 55 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 94 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 11 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 9 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 69 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 98 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 83 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 100 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 43 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 64 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 75 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 94 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 4 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus | 3 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 69 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 98 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 92 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 100 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 43 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 66 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 75 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 94 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 4 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus | 3 percentage of participants |
Secondary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).
Time frame: Day 181
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 10.5 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 40.0 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 35.1 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 79.5 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 9.9 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 11.5 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 9.5 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 42.7 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 5.1 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 6.2 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 13.9 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 54.2 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 36.2 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 113.9 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 9.9 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 18.1 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 16.8 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 91.8 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 6.1 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus | 6.1 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).
Time frame: Day 181
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 24.1 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 105.3 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 73.4 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 296.3 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 14.3 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 17.0 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 34.6 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 110.7 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 5.4 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 10.2 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 34.3 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 153.2 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 108.9 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 482.5 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 17.5 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 31.4 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 45.2 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 320.0 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 5.9 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 7.0 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Blood was collected for HAI assay which was conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 18.7 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 92.7 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 62.6 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 166.3 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 9.0 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 21.0 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 27.3 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 146.7 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 5.3 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 6.1 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Blood was collected for Neutralizing assay which was conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 98.5 titer |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 515.4 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 329.4 titer |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 1015.9 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 39.3 titer |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 102.1 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 171.5 titer |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 744.8 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 7.0 titer |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 10.1 titer |
Secondary
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), 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 through Day 366
Population: The safety population includes all participants who received study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 5 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 1 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 8 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 5 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 6 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 1 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 13 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 2 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 7 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 8 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 4 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 10 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMC | 1 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAE | 3 Participants |
Secondary
Number of Participants Reporting Unsolicited Non-serious AEs
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 21 days after study vaccination.
Time frame: Day 1 through Day 22
Population: The safety population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Number of Participants Reporting Unsolicited Non-serious AEs | 9 Participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Unsolicited Non-serious AEs | 10 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Number of Participants Reporting Unsolicited Non-serious AEs | 3 Participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Unsolicited Non-serious AEs | 4 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Number of Participants Reporting Unsolicited Non-serious AEs | 15 Participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Unsolicited Non-serious AEs | 10 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Number of Participants Reporting Unsolicited Non-serious AEs | 7 Participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Unsolicited Non-serious AEs | 5 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Number of Participants Reporting Unsolicited Non-serious AEs | 8 Participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Number of Participants Reporting Unsolicited Non-serious AEs | 7 Participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 181 is 180 days post study vaccination.
Time frame: Day 181
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 20 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 53 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 50 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 72 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 18 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 18 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 20 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 50 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 0 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Blood was collected for the HAI assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days post study vaccination.
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 34 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 85 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 75 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 89 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 15 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 45 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 55 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 94 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 0 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days post study vaccination.
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 28 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 60 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 58 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 83 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 18 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 34 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 35 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 75 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 4 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 180 days post second vaccination (Day 181).
Time frame: Day 181
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 20 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 55 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 54 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 78 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 18 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 25 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 20 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 56 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 0 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 6 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Blood was collected for the HAI assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post second vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 34 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 85 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 75 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 94 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 15 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 45 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 55 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 94 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 0 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm and stratum from the available results at 7 days post second vaccination (Day 8).
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 28 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 65 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 63 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 83 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 18 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 41 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 35 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 81 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 7 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 6 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after study vaccination is Day 181.
Time frame: Day 181
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 31 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 73 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 63 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 94 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 23 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 32 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 42 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 88 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 0 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 9 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 74 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 98 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 96 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 100 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 50 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 84 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 90 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 100 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 4 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 7 days after study vaccination is Day 8.
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 53 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 80 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 75 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 100 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 33 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 48 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 55 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 88 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 4 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 9 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).
Time frame: Day 181
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 31 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 75 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 67 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 94 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 23 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 32 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 42 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 88 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 0 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus | 9 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 74 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 98 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 96 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 100 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 50 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 84 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 90 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 100 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 4 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) | 6 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 53 percentage of participants |
| 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 80 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 79 percentage of participants |
| 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 100 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 33 percentage of participants |
| 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 48 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 55 percentage of participants |
| 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 94 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 4 percentage of participants |
| A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus | 9 percentage of participants |