Avian Influenza, Influenza Immunisation
Conditions
Keywords
A/H7N9, Adults, AS03, Immunogenicity, Influenza, Prime-Boost, Reactogenicity, Safety, Vaccine
Brief summary
This is a trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines administered intramuscularly at different dosages, given with or without AS03 adjuvant, using different vaccination schedules. This trial will enroll up to 180 males and non-pregnant females, 19 to 50 years of age, who are in good health and who are influenza A/H7 naïve. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) to evaluate the interval between the first and second doses and the presence of the adjuvant in the first and second doses. The neuraminidase-specific antibody response and the neuraminidase content of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently under development. Study duration is approximately 22 months with subject participation duration of approximately 18 months. The primary objectives of the study are: 1) to assess the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second study vaccine.
Detailed description
This is a Phase II trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines (2013 and 2017 A/H7N9 IIVs) administered intramuscularly at different dosages (3.75 or 15 mcg of hemagglutinin (HA) per dose), given with or without AS03 adjuvant, using different heterologous and homologous prime-boost vaccination schedules. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. This trial will enroll up to 180 males and non-pregnant females, 19 to 50 years of age, inclusive, who are in good health and meet all eligibility criteria and who are influenza A/H7 vaccine/infection naïve by medical history. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) evaluating the interval between the priming (first) and boosting (second) doses and the presence of the adjuvant in the priming (first) and boosting (second) doses. The neuraminidase-specific antibody response and the neuraminidase content of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently under development. Study duration is approximately 22 months with subject participation duration of approximately 18 months. The primary objectives of the study are: 1) to assess the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second study vaccine. The secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of each study vaccine; 2) to assess medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs), following receipt of each study vaccine; 3) to assess the kinetics and durability of serum HAI and Neut antibody responses following receipt of each study vaccine.
Interventions
BIOLOGICALA/H7N9
Monovalent split 2017 A/H7N9 Inictivated Influenza Virus vaccine containing the HA and 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).
DRUGAS03
AS03 oil-in-water emulsion adjuvant.
Monovalent split 2013 A/H7N9 Inavtivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).
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 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. 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 50 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 (ER), or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject
Exclusion criteria
), herbals, vitamins, and supplements are permitted. 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 first study vaccination until 60 days after last 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 of the last menses if menopausal. \-- Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing(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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 22 through Day 29 | Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination. |
| Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 43 | Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43). |
| Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 142 | Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142 ). |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 43 | Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43). |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 142 | Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142). |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 43 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 142 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 43 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 142 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142. |
| Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 43 | Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43). |
| Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 142 | Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 142). |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 43 | Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43). |
| Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 142 | Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142). |
| Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 387 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 1 through Day 387 | SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation; or a congenital anomaly/birth defect. |
| Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 1 through Day 486 | SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation; or a congenital anomaly/birth defect. |
| Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Day 1 through Day 8 | Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher. |
| Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 121 through Day 128 | Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher. |
| Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 22 through Day 29 | Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher. |
| Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | Day 1 through Day 8 | Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination. |
| Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 121 through Day 128 | Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination. |
| Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Day 22 through Day 29 | Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination. |
| Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | Day 1 through Day 8 | Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination. |
| Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 121 through Day 128 | Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 301 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301). |
| Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | Day 1 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1). |
| Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Day 22 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22). |
| Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 202 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 202). |
| Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 121 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121). |
| Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 301 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301). |
| Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Day 1 through Day 387 | 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 Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Day 1 through Day 486 | 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 Post First Vaccination From Day 1 Through Day 22 | 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 the first study vaccination. |
| Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 121 through Day 142 | 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 the second study vaccination. |
| Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 22 Through Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 22 through Day 43 | 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 the second study vaccination. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Day 22 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 first study vaccination is Day 22. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 202 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. 180 days after second study vaccination is Day 202. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 121 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. Immediately prior to second study vaccination is Day 121. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 301 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. 180 days after second study vaccination is Day 301. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Day 22 | Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 first study vaccination is Day 22. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 202 | Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 second study vaccination is Day 202. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 121 | Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. Immediately prior to second study vaccination is Day 121. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 301 | Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 second study vaccination is Day 301. |
| Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | Day 1 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1). |
| Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Day 22 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22). |
| Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 202 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 202). |
| Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 121 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121). |
| Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 301 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 301). |
| Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | Day 1 | Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1). |
| Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Day 22 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22). |
| Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 202 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 202). |
| Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 121 | Blood was collected for NEUT assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121). |
| Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | Day 301 | Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301). |
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | Day 1 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1). |
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Day 22 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22). |
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | Day 202 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 202). |
| Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | Day 121 | Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) 3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22. | 27 |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) 3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121. | 30 |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) 3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121. | 33 |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22. | 32 |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121. | 28 |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) 3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121. | 30 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Enrolled but treatment not administered | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 | 3 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 5 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 8.2 | 29.7 years STANDARD_DEVIATION 7.5 | 29.6 years STANDARD_DEVIATION 7.7 | 32.8 years STANDARD_DEVIATION 9.2 | 31.2 years STANDARD_DEVIATION 7.7 | 30.6 years STANDARD_DEVIATION 8.4 | 31.0 years STANDARD_DEVIATION 8.1 |
| Age, Customized 19-34 | 16 participants | 24 participants | 25 participants | 19 participants | 19 participants | 19 participants | 122 participants |
| Age, Customized 35-50 | 11 participants | 6 participants | 8 participants | 13 participants | 9 participants | 11 participants | 58 participants |
| Body Mass Index (BMI) | 27.07 kg/m^2 STANDARD_DEVIATION 3.32 | 25.02 kg/m^2 STANDARD_DEVIATION 4.27 | 28.32 kg/m^2 STANDARD_DEVIATION 5.93 | 26.32 kg/m^2 STANDARD_DEVIATION 4.96 | 27.17 kg/m^2 STANDARD_DEVIATION 6.15 | 28.18 kg/m^2 STANDARD_DEVIATION 6.8 | 27.02 kg/m^2 STANDARD_DEVIATION 5.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 26 Participants | 29 Participants | 28 Participants | 25 Participants | 28 Participants | 161 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Prior Receipt of H5 Influenza Vaccine No Prior H5 Influenza Vaccination(s) Reported | 24 Participants | 29 Participants | 30 Participants | 31 Participants | 27 Participants | 28 Participants | 169 Participants |
| Prior Receipt of H5 Influenza Vaccine Reported Receipt of Prior H5 Influenza Vaccination(s) | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 11 Participants |
| Prior Seasonal Influenza Vaccination (Current Season) 2018-2019 Not Reported | 21 Participants | 27 Participants | 27 Participants | 25 Participants | 22 Participants | 25 Participants | 147 Participants |
| Prior Seasonal Influenza Vaccination (Current Season) 2018-2019 Reported | 6 Participants | 3 Participants | 6 Participants | 7 Participants | 6 Participants | 5 Participants | 33 Participants |
| Prior Seasonal Influenza Vaccination (Prior Seasons) 2016-2017 Not Reported | 12 Participants | 14 Participants | 19 Participants | 12 Participants | 9 Participants | 13 Participants | 79 Participants |
| Prior Seasonal Influenza Vaccination (Prior Seasons) 2016-2017 Reported | 15 Participants | 16 Participants | 14 Participants | 20 Participants | 19 Participants | 17 Participants | 101 Participants |
| Prior Seasonal Influenza Vaccination (Prior Seasons) 2017-2018 Not Reported | 10 Participants | 12 Participants | 11 Participants | 12 Participants | 8 Participants | 12 Participants | 65 Participants |
| Prior Seasonal Influenza Vaccination (Prior Seasons) 2017-2018 Reported | 17 Participants | 18 Participants | 22 Participants | 20 Participants | 20 Participants | 18 Participants | 115 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 11 Participants | 6 Participants | 9 Participants | 4 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 22 Participants | 20 Participants | 23 Participants | 17 Participants | 21 Participants | 121 Participants |
| Region of Enrollment United States | 27 participants | 30 participants | 33 participants | 32 participants | 28 participants | 30 participants | 180 participants |
| Sex: Female, Male Female | 11 Participants | 19 Participants | 23 Participants | 19 Participants | 19 Participants | 15 Participants | 106 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 10 Participants | 13 Participants | 9 Participants | 15 Participants | 74 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 30 | 0 / 33 | 0 / 32 | 0 / 27 | 0 / 30 |
| other Total, other adverse events | 27 / 27 | 30 / 30 | 33 / 33 | 31 / 32 | 27 / 27 | 29 / 30 |
| serious Total, serious adverse events | 0 / 27 | 0 / 30 | 1 / 33 | 2 / 32 | 0 / 27 | 1 / 30 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 142).
Time frame: Day 142
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 97.2 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 53.8 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 22.6 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 43.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 50.6 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 133.4 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 33.2 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 17.0 titer |
Primary
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Time frame: Day 43
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 35.9 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 75.7 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 19.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 65.0 titer |
Primary
Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142).
Time frame: Day 142
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 286.6 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 146.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 67.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 117.0 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 178.0 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 202.0 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 62.7 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 64.7 titer |
Primary
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Time frame: Day 43
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 86.4 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 55.7 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 38.7 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 51.2 titer |
Primary
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 post first vaccination were included for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | WBC | 3 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Creatinine | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Hemoglobin | 2 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Total Bilirubin | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | ALT | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Platelets | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Platelets | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Creatinine | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | WBC | 4 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Total Bilirubin | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | ALT | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Hemoglobin | 3 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | WBC | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | ALT | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Hemoglobin | 2 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Platelets | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Total Bilirubin | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Creatinine | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Hemoglobin | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Creatinine | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | ALT | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Total Bilirubin | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | WBC | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Platelets | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Hemoglobin | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Creatinine | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Platelets | 4 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Total Bilirubin | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | WBC | 2 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | ALT | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | ALT | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | WBC | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Creatinine | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Hemoglobin | 2 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Platelets | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8 | Total Bilirubin | 1 Participants |
Primary
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
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 121 through Day 128
Population: The Safety Analysis population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 post second vaccination were included for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Platelets | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | ALT | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Total Bilirubin | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Creatinine | 3 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Hemoglobin | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | WBC | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | WBC | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Total Bilirubin | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Platelets | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | ALT | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Hemoglobin | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Creatinine | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Hemoglobin | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | ALT | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Platelets | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Creatinine | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | WBC | 3 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Total Bilirubin | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Creatinine | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Platelets | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | ALT | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Total Bilirubin | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | Hemoglobin | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | WBC | 1 Participants |
Primary
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
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 22 through Day 29
Population: The Safety Analysis population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 post second vaccination were included for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | WBC | 4 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | ALT | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Total Bilirubin | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Hemoglobin | 1 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Creatine | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Platelets | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Creatine | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | WBC | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Platelets | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | ALT | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Total Bilirubin | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | Hemoglobin | 3 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 387 in Participants Who Received Their Second Study Vaccination on Day 22.
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 387
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 387 in Participants Who Received Their Second Study Vaccination on Day 22. | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 387 in Participants Who Received Their Second Study Vaccination on Day 22. | 2 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121.
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 486
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121. | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121. | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121. | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121. | 1 Participants |
Primary
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From 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.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 25 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 27 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 30 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 28 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 26 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 29 Participants |
Primary
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Time frame: Day 121 through Day 128
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | 23 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | 12 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | 24 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121. | 10 Participants |
Primary
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Time frame: Day 22 through Day 29
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | 22 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | 21 Participants |
Primary
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From 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.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 17 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 12 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 18 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 10 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 17 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8 | 16 Participants |
Primary
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Time frame: Day 121 through Day 128
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121 | 7 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121 | 9 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121 | 12 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121 | 7 Participants |
Primary
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Time frame: Day 22 through Day 29
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | 17 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22. | 10 Participants |
Primary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142.
Time frame: Day 142
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 77 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 86 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 55 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 32 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 69 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 85 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 19 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 56 percentage of participants |
Primary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43.
Time frame: Day 43
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 52 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 78 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 35 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 81 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142.
Time frame: Day 142
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 91 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Against A/Shanghai/2/2013 (A/H7N9) | 95 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 77 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Against A/Shanghai/2/2013 (A/H7N9) | 84 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Against A/Shanghai/2/2013 (A/H7N9) | 92 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 92 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | Against A/Shanghai/2/2013 (A/H7N9) | 63 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 70 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43.
Time frame: Day 43
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | Against A/Shanghai/2/2013 (A/H7N9) | 85 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 74 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | Against A/Shanghai/2/2013 (A/H7N9) | 55 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 74 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142).
Time frame: Day 142
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 95 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 91 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 77 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 87 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 92 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 92 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 67 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 70 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22
Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Time frame: Day 43
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 85 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 74 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 55 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 74 percentage of participants |
Primary
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142 ).
Time frame: Day 142
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 77 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 86 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 61 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 32 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 69 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 92 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 19 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 59 percentage of participants |
Primary
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Time frame: Day 43
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 52 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 81 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Shanghai/2/2013 (A/H7N9) | 35 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22. | A/Hong Kong/125/2017 (A/H7N9) | 81 percentage of participants |
Secondary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Time frame: Day 1
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 7.4 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 5.6 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 6.8 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 6.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 7.3 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 6.0 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 5.5 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Time frame: Day 121
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 7.7 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 9.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 8.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 9.8 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121. | A/Hong Kong/125/2017 (A/H7N9) | 6.4 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 202).
Time frame: Day 202
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 8.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 24.7 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 7.4 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 20.8 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first 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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 8.8 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 9.7 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 7.9 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 8.8 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 7.6 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 8.2 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 7.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 14.6 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 8.9 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 10.1 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301).
Time frame: Day 301
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 13.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 47.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 13.8 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 8.8 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 11.9 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 38.8 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 7.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 8.5 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Time frame: Day 1
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 5.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9 | 5.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 5.4 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9 | 5.5 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9 | 5.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 5.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 5.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9 | 5.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 5.0 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9 | 5.2 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9 | 5.1 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 5.5 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Time frame: Day 121
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 13.9 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 11.2 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 10.7 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 14.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 8.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 9.9 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 8.2 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 8.7 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 202).
Time frame: Day 202
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 26.9 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 18.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 13.3 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 14.8 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first 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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 8.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Against A/Shanghai/2/2013 (A/H7N9) | 11.5 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 7.1 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Against A/Shanghai/2/2013 (A/H7N9) | 8.9 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Against A/Shanghai/2/2013 (A/H7N9) | 9.6 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 7.5 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Against A/Shanghai/2/2013 (A/H7N9) | 6.7 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 8.3 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Against A/Shanghai/2/2013 (A/H7N9) | 6.6 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 8.6 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 9.3 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | Against A/Shanghai/2/2013 (A/H7N9) | 7.7 titer |
Secondary
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301).
Time frame: Day 301
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 52.8 titer |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 30.3 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 17.8 titer |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 27.9 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 29.9 titer |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 31.2 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 14.9 titer |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 15.8 titer |
Secondary
Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From 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 the first study vaccination.
Time frame: Day 1 through Day 22
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22 | 9 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22 | 10 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22 | 15 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22 | 8 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22 | 3 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22 | 4 Participants |
Secondary
Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121
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 the second study vaccination.
Time frame: Day 121 through Day 142
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | 5 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | 8 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | 4 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121 | 0 Participants |
Secondary
Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 22 Through Day 43 in Participants Who Received Their Second Study Vaccination on Day 22
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 the second study vaccination.
Time frame: Day 22 through Day 43
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 22 Through Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | 7 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 22 Through Day 43 in Participants Who Received Their Second Study Vaccination on Day 22 | 4 Participants |
Secondary
Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
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 486
Population: The Safety Analysis population includes all participants who received study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 12 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Potentially Immune Mediated Medical Conditions | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | New Onset Chronic Medical Conditions | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 11 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Potentially Immune Mediated Medical Conditions | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | New Onset Chronic Medical Conditions | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | New Onset Chronic Medical Conditions | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 10 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Potentially Immune Mediated Medical Conditions | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 7 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Potentially Immune Mediated Medical Conditions | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | New Onset Chronic Medical Conditions | 1 Participants |
Secondary
Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
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 387
Population: The Safety Analysis population includes all participants who received study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 9 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | New Onset Chronic Medical Conditions | 0 Participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Potentially Immune-Mediated Medical Conditions | 0 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 8 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | New Onset Chronic Medical Conditions | 1 Participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Potentially Immune-Mediated Medical Conditions | 0 Participants |
Secondary
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Time frame: Day 1
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 11 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 6 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 6 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 3 percentage of participants |
Secondary
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Time frame: Day 121
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 20 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 6 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 11 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 7 percentage of participants |
Secondary
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 202).
Time frame: Day 202
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 48 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 37 percentage of participants |
Secondary
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post first 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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 15 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 14 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 12 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 29 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 11 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 17 percentage of participants |
Secondary
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 301).
Time frame: Day 301
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 10 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 75 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 30 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 12 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 64 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. Immediately prior to second study vaccination is Day 121.
Time frame: Day 121
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 16 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 6 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 11 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 7 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. 180 days after second study vaccination is Day 202.
Time frame: Day 202
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 41 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 33 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 first 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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 11 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 11 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 9 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 26 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 11 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 17 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. 180 days after second study vaccination is Day 301.
Time frame: Day 301
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 10 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 75 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 26 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 12 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 56 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
Secondary
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for NEUT assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Time frame: Day 121
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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 12 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 3 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 9 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
Secondary
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 202).
Time frame: Day 202
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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 33 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 19 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 10 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 13 percentage of participants |
Secondary
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post first 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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 11 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 3 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 7 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301).
Time frame: Day 301
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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 70 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 45 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 22 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 44 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 48 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 56 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 20 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 16 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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. Immediately prior to second study vaccination is Day 121.
Time frame: Day 121
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 12 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 3 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 9 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 second study vaccination is Day 202.
Time frame: Day 202
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 30 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 19 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 10 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 13 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 first 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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 11 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 3 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 7 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22 | A/Hong Kong/125/2017 (A/H7N9) | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. 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 second study vaccination is Day 301.
Time frame: Day 301
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 70 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 45 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 22 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 44 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 48 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 56 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Shanghai/2/2013 (A/H7N9) | 20 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121 | A/Hong Kong/125/2017 (A/H7N9) | 16 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Time frame: Day 1
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 | Group | Value (NUMBER) |
|---|---|---|---|
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 4 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Shanghai/2/2013 (A/H7N9) | 3 percentage of participants |
| 2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121) | Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1 | A/Hong Kong/125/2017 (A/H7N9) | 0 percentage of participants |