Avian Influenza, Influenza Immunisation
Conditions
Keywords
A/H7N9, Immunogenicity, Influenza, Safety, Sanofi Pasteur, Vaccine
Brief summary
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females 19 years and older that is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) administered at different dosages given with AS03 adjuvant and phosphate buffered saline (PBS) diluent, with AS03 adjuvant only, and without adjuvant. Eligible subjects will be randomized into 5 study groups, stratified by age. The study will enroll up to 420 individuals 19-64 years old and up to 300 individuals who are 65 years old and older. Study duration is approximately 16 months with subject participation duration approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart given with or without AS03 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of recipient.
Detailed description
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females 19 years and older. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) administered at different dosages given with or without adjuvant. 3.75 mcg of HA per dose will be administered with phosphate buffered saline (PBS) diluent and AS03 adjuvant, 7.5 mcg and 15 mcg of HA per dose will be administered with AS03 adjuvant only, and 15 mcg and 45 mcg of HA per dose will be administered without adjuvant. Eligible subjects will be randomized into one of 5 study groups, stratified by age. The study will enroll up to 420 individuals 19-64 years old and up to 300 individuals who are 65 years old and older. The study duration is approximately 16 months with subject participation duration approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart given with or without AS03 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of recipient. The secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of two doses of a 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without AS03 adjuvant; 2) to assess medically-attended adverse events (MAAEs) including new-onset chronic medical conditions (NOCMCs), potentially immune-mediated medical conditions (PIMMCs), and all serious adverse events (SAEs) following receipt of two doses of a 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without AS03 adjuvant; 3) to assess the serum HAI and Neut antibody responses approximately 7 and 21 days following receipt of a single dose, and approximately 7 days following receipt of two doses of 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of recipient.
Interventions
DRUGAS03
Oil-in-water emulsion based adjuvant system.
BIOLOGICALInactivated influenza H7N9 vaccine
Monovalent 2017 H7N9 inactivated influenza vaccine
Diluent for 2017 Monovalent Inactivated Influenza A/H7N9 virus vaccine (2017 H7N9 IIV)
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 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females, 19 years of age and older, inclusive. 4. Are in good health\*. \*As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER, or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject
Exclusion criteria
), herbals, vitamins, and supplements are permitted. 5. Oral temperature is less than 100.0 degrees Fahrenheit. 6. Pulse is 47 to 100 bpm, inclusive. 7. Systolic blood pressure is 85 to 150 mmHg, inclusive (subjects \<65 years of age), 85 to 160 mmHg, inclusive (subjects = / \> 65 years of age). 8. Diastolic blood pressure is 55 to 95 mmHg, inclusive. 9. Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour. 10. Women of childbearing potential\* must use an acceptable contraception method\*\* from 30 days before first study vaccination until 60 days after last study vaccination. \*Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(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. \*\*Acceptable contraception 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). 11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 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 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 43. |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | Day 43 | Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9. |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | Day 43 | Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9. |
| Number of Participants With Clinical Safety Laboratory Adverse Events | Day 8 | Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher. |
| Number of Participants Reporting Solicited Injection Site Events | Day 1 to 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 dailyactivities), 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 Study Vaccine-related Serious Adverse Events (SAEs) | Day 1 to 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. Events are included if deemed by the investigator to be related to the study product. |
| Number of Participants Reporting Systemic Reactogenicity Events | Day 1 to Day 8 | Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater | 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. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at 21 days after second dose of H7N9. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater | 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. The percentage of participants with Neut titer \>= 1:40 was calculated for each study group from the available results at 21 days after second dose of H7N9. |
| Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 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 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 43. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | Day 1 | Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at baseline. |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | Day 1 | Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at baseline. |
| Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness | Day 1 to 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. All events are included regardless of relationship to the study product. |
| Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness | Day 1 to 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 each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Day 1 to Day 387 | For each unsolicited AE experienced, the participants were asked if he/she had received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. AEs characterized by such unscheduled medical care were designated as MAAEs. NOCMCs are defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study agent, that is expected to continue for at least 3 months and requires continued health care intervention. PIMMCs constitute a group of AEs that includes diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies. |
| Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs) | Day 1 to 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 each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC). |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | Day 1 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at baseline. |
| Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | Day 1 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study group from the available results at baseline. |
| Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | Day 8 | Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days after the first dose of H7N9. |
| Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | Day 8 | Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days after the first dose of H7N9. |
Countries
United States
Participant flow
Recruitment details
Participants were healthy males and non-pregnant females aged 19 years and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 14FEB2018 and 05SEP2018.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22
Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine
AS03: Oil-in-water emulsion based adjuvant system. | 183 |
| Group 2 7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22
Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine
AS03: Oil-in-water emulsion based adjuvant system. | 175 |
| Group 3 15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22
Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine
AS03: Oil-in-water emulsion based adjuvant system. | 180 |
| Group 4 15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22
Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine | 89 |
| Group 5 45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22
Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine | 90 |
| Total | 717 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 6 | 1 | 3 | 1 |
| Overall Study | Study Vaccination not Received | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Group 4 | Group 5 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 20 | 51.2 years STANDARD_DEVIATION 20 | 51.5 years STANDARD_DEVIATION 20.2 | 53.2 years STANDARD_DEVIATION 18.6 | 51.9 years STANDARD_DEVIATION 19 | 52.0 years STANDARD_DEVIATION 19.7 |
| Body Mass Index (BMI) | 27.5 kg/m^2 STANDARD_DEVIATION 5.3 | 28.2 kg/m^2 STANDARD_DEVIATION 6.5 | 26.8 kg/m^2 STANDARD_DEVIATION 5.4 | 27.2 kg/m^2 STANDARD_DEVIATION 5.8 | 27.5 kg/m^2 STANDARD_DEVIATION 4.3 | 27.5 kg/m^2 STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 9 Participants | 7 Participants | 6 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 179 Participants | 169 Participants | 170 Participants | 82 Participants | 84 Participants | 684 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 8 Participants | 14 Participants | 1 Participants | 3 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 22 Participants | 25 Participants | 13 Participants | 10 Participants | 89 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 5 Participants | 7 Participants | 4 Participants | 2 Participants | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 4 Participants | 1 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) White | 149 Participants | 137 Participants | 130 Participants | 69 Participants | 73 Participants | 558 Participants |
| Region of Enrollment United States | 183 participants | 175 participants | 180 participants | 89 participants | 90 participants | 717 participants |
| Sex: Female, Male Female | 94 Participants | 99 Participants | 81 Participants | 47 Participants | 50 Participants | 371 Participants |
| Sex: Female, Male Male | 89 Participants | 76 Participants | 99 Participants | 42 Participants | 40 Participants | 346 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 183 | 1 / 175 | 1 / 180 | 0 / 89 | 0 / 90 |
| other Total, other adverse events | 172 / 183 | 170 / 175 | 167 / 180 | 70 / 89 | 73 / 90 |
| serious Total, serious adverse events | 4 / 183 | 9 / 175 | 4 / 180 | 3 / 89 | 1 / 90 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9.
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 | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 33.6 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 33.5 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 39.2 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.5 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 6.3 titer |
Primary
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9.
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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 45.2 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 46.1 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 49.7 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 6.2 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 7.8 titer |
Primary
Number of Participants Reporting Solicited Injection Site Events
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with dailyactivities), 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 to Day 29
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Solicited Injection Site Events | 122 Participants |
| Group 2 | Number of Participants Reporting Solicited Injection Site Events | 116 Participants |
| Group 3 | Number of Participants Reporting Solicited Injection Site Events | 140 Participants |
| Group 4 | Number of Participants Reporting Solicited Injection Site Events | 35 Participants |
| Group 5 | Number of Participants Reporting Solicited Injection Site Events | 33 Participants |
Primary
Number of Participants Reporting Solicited Injection Site Events
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with dailyactivities), 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 to Day 8
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Solicited Injection Site Events | 145 Participants |
| Group 2 | Number of Participants Reporting Solicited Injection Site Events | 153 Participants |
| Group 3 | Number of Participants Reporting Solicited Injection Site Events | 154 Participants |
| Group 4 | Number of Participants Reporting Solicited Injection Site Events | 36 Participants |
| Group 5 | Number of Participants Reporting Solicited Injection Site Events | 46 Participants |
Primary
Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs)
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Events are included if deemed by the investigator to be related to the study product.
Time frame: Day 1 to Day 387
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
| Group 2 | Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
| Group 3 | Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
| Group 4 | Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
| Group 5 | Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Events
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Time frame: Day 22 to Day 29
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Systemic Reactogenicity Events | 75 Participants |
| Group 2 | Number of Participants Reporting Systemic Reactogenicity Events | 64 Participants |
| Group 3 | Number of Participants Reporting Systemic Reactogenicity Events | 72 Participants |
| Group 4 | Number of Participants Reporting Systemic Reactogenicity Events | 19 Participants |
| Group 5 | Number of Participants Reporting Systemic Reactogenicity Events | 17 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Events
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time frame: Day 1 to Day 8
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Systemic Reactogenicity Events | 76 Participants |
| Group 2 | Number of Participants Reporting Systemic Reactogenicity Events | 81 Participants |
| Group 3 | Number of Participants Reporting Systemic Reactogenicity Events | 72 Participants |
| Group 4 | Number of Participants Reporting Systemic Reactogenicity Events | 27 Participants |
| Group 5 | Number of Participants Reporting Systemic Reactogenicity Events | 31 Participants |
Primary
Number of Participants With Clinical Safety Laboratory Adverse Events
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Time frame: Day 29
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine. Participants who completed Day 29 visit were included for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 10 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 7 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 3 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 2 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 2 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 2 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 5 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 4 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 14 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 2 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 3 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 8 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 2 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 2 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 14 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 2 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 5 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 3 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 1 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 6 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 1 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 2 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 0 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 7 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 1 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 3 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 3 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 3 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 0 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 4 Participants |
Primary
Number of Participants With Clinical Safety Laboratory Adverse Events
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Time frame: Day 8
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine. Participants who completed Day 8 visit were included for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 8 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 4 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 4 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 3 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 0 Participants |
| Group 1 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 2 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 3 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 5 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 18 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 7 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 5 Participants |
| Group 2 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 5 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 3 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 2 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 16 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 1 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 3 Participants |
| Group 3 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 4 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 1 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 8 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 2 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 2 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 4 Participants |
| Group 4 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 6 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Total Bilirubin | 1 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelets | 3 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 5 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 3 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 1 Participants |
| Group 5 | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 5 Participants |
Primary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at 21 days after second dose of H7N9.
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater | 57 percentage of participants |
| Group 2 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater | 56 percentage of participants |
| Group 3 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater | 61 percentage of participants |
| Group 4 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater | 2 percentage of participants |
Primary
Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study group from the available results at 21 days after second dose of H7N9.
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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater | 64 proportion of participants |
| Group 2 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater | 65 proportion of participants |
| Group 3 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater | 68 proportion of participants |
| Group 4 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater | 0 proportion of participants |
| Group 5 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater | 3 proportion of participants |
Primary
Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is 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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 56 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 56 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 61 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 2 percentage of participants |
Primary
Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
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 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is 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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 64 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 64 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 67 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 2 percentage of participants |
Secondary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at baseline.
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 | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.2 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.2 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.2 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.3 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.4 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 7 days post first vaccination.
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.3 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.6 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.8 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.3 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 6.0 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first vaccination.
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 6.7 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 7.0 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 7.6 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.5 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 6.0 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 7 days post second vaccination.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 36.7 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 45.1 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 45.7 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 5.4 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies | 6.8 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first vaccination.
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 | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 8.4 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 9.1 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 9.9 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.4 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 6.9 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at baseline.
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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.2 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.3 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.3 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.3 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.5 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 7 days post first vaccination.
Time frame: Day 8
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 | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.6 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 6.4 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 6.6 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 5.5 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 6.3 titer |
Secondary
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 7 days post second vaccination.
Time frame: Day 29
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 | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 43.6 titer |
| Group 2 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 53.9 titer |
| Group 3 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 54.7 titer |
| Group 4 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 6.1 titer |
| Group 5 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies | 8.1 titer |
Secondary
Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs)
For each unsolicited AE experienced, the participants were asked if he/she had received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. AEs characterized by such unscheduled medical care were designated as MAAEs. NOCMCs are defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study agent, that is expected to continue for at least 3 months and requires continued health care intervention. PIMMCs constitute a group of AEs that includes diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies.
Time frame: Day 1 to Day 387
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 69 Participants |
| Group 1 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Potentially Immune-Mediated Medical Conditions | 2 Participants |
| Group 1 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | New-Onset Chronic Medical Conditions | 17 Participants |
| Group 2 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | New-Onset Chronic Medical Conditions | 7 Participants |
| Group 2 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 59 Participants |
| Group 2 | Number of Participants 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 |
| Group 3 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | New-Onset Chronic Medical Conditions | 7 Participants |
| Group 3 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 65 Participants |
| Group 3 | Number of Participants 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 |
| Group 4 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 33 Participants |
| Group 4 | Number of Participants 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 |
| Group 4 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | New-Onset Chronic Medical Conditions | 7 Participants |
| Group 5 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | New-Onset Chronic Medical Conditions | 4 Participants |
| Group 5 | Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Medically-Attended Adverse Events | 25 Participants |
| Group 5 | Number of Participants 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
Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All events are included regardless of relationship to the study product.
Time frame: Day 1 to Day 387
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness | 4 Participants |
| Group 2 | Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness | 9 Participants |
| Group 3 | Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness | 4 Participants |
| Group 4 | Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness | 3 Participants |
| Group 5 | Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness | 1 Participants |
Secondary
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs)
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 21 days after each vaccination. The site investigator determined vaccine related as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Day 1 to Day 43
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs) | 19 Participants |
| Group 2 | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs) | 14 Participants |
| Group 3 | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs) | 12 Participants |
| Group 4 | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs) | 4 Participants |
| Group 5 | Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs) | 4 Participants |
Secondary
Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness
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 each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Day 1 to Day 43
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness | 72 Participants |
| Group 2 | Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness | 62 Participants |
| Group 3 | Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness | 67 Participants |
| Group 4 | Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness | 23 Participants |
| Group 5 | Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness | 27 Participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at 7 days post second vaccination.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 57 percentage of participants |
| Group 2 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 65 percentage of participants |
| Group 3 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 64 percentage of participants |
| Group 4 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 5 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at baseline.
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 2 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 3 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 4 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at 7 days post first vaccination.
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 1 percentage of participants |
| Group 2 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 2 percentage of participants |
| Group 3 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 2 percentage of participants |
| Group 4 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at 21 days post first vaccination.
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 3 percentage of participants |
| Group 2 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 5 percentage of participants |
| Group 3 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 7 percentage of participants |
| Group 4 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 1 percentage of participants |
| Group 5 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study group from the available results at 7 days post first vaccination.
Time frame: Day 8
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 2 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 3 percentage of participants |
| Group 3 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 2 percentage of participants |
| Group 4 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study group from the available results at baseline.
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 Neut antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 2 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 1 percentage of participants |
| Group 3 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 4 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 1 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study group from the available results at 21 days post first vaccination.
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 2 percentage of participants |
| Group 2 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 5 percentage of participants |
| Group 3 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 6 percentage of participants |
| Group 4 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 3 percentage of participants |
Secondary
Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study group from the available results at 7 days post second vaccination.
Time frame: Day 29
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 61 percentage of participants |
| Group 2 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 71 percentage of participants |
| Group 3 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 67 percentage of participants |
| Group 4 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater | 6 percentage of participants |
Secondary
Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days after the first dose of H7N9.
Time frame: Day 8
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 0 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 1 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 2 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days after the first dose of H7N9.
Time frame: Day 22
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 3 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 5 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 7 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 1 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 29 is 7 days after the second dose of H7N9.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 56 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 65 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 64 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies | 5 percentage of participants |
Secondary
Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
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 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days after the first dose of H7N9.
Time frame: Day 8
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 0 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 2 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 2 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
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 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days after the first dose of H7N9.
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 2 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 5 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 6 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 2 percentage of participants |
Secondary
Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
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 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 29 is 7 days after the second dose of H7N9.
Time frame: Day 29
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 | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 60 percentage of participants |
| Group 2 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 70 percentage of participants |
| Group 3 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 67 percentage of participants |
| Group 4 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 0 percentage of participants |
| Group 5 | Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies | 6 percentage of participants |