Influenza, Human
Conditions
Keywords
Pandemic, Influenza, Vaccine, MF59, Adjuvant
Brief summary
This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of vaccination with different MF59-adjuvanted H5N1 vaccine formulations.
Interventions
BIOLOGICALH5N1 antigen combined with MF59 adjuvant
Eligible subjects will be stratified by age at the time of enrollment into one of 2 age cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 vaccine 3 weeks apart
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female subjects of 6 months through \<9 years of age on the day of informed consent/assent. 2. Documented consent provided by the subject's parent(s)/LAR(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Subject's parent(s)/LAR(s) able to comprehend and comply with all study procedures, and available for all clinic visits and telephone contacts scheduled in the study. 4. Subjects must provide a baseline blood sample within 10 days prior to the Day 1 vaccination.
Exclusion criteria
Each subject must not have: 1. Progressive, unstable or uncontrolled clinical conditions. 2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws, ie, 1. Subjects who have had a fever (body temperature measurement ≥ 38°C) within three days prior to vaccination. The subject may return for vaccination after they have been free of fever for three days. 2. History of epilepsy or convulsions (excluding febrile convulsions). 3. A subject who has any medical condition meeting the definition of AESI defined for the purposes of this trial (see appendix A). 4. Subjects who have received antipyretic medication within the past 24 hours prior to vaccination. The subject may return for vaccination after a period of 24 hours has passed since the administration of an antipyretic. 4. Abnormal function of the immune system resulting from: 1. Clinical conditions. 2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent/assent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted. 3. Administration of antineoplastic and immunomodulating agents or radiotherapy from within 90 days prior to informed consent/assent. 5. Suspicion of pandemic influenza illness within past six months or have ever received previous pandemic H5N1 flu vaccination. 6. Received immunoglobulins or any blood products within 180 days prior to informed consent/assent. 7. Received an investigational or non-registered medicinal within 30 days prior to informed consent/assent. 8. Children of study site staff (this includes research or clinic staff) or children who are otherwise related to study site staff or have household members who are study site staff. Study site staff are employees with direct or indirect contact with study subjects and/or have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, medical assistants, document scanners, etc. study personnel as an immediate family or household member. 9. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. 10. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine prior to day 43. Following day 43 other vaccines may be administered, including seasonal flu.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | Day 1 (baseline), Day 22, and Day 43 | Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1, Day 22, and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses. |
| Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Day 1 through Day 387 | Percentages of subjects reporting SAEs, NOCDs, AESIs, and AEs leading to vaccine and/or study withdrawal, as collected from Day 1 through Day 387, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses. |
| Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | Day 1 (baseline), Day 22, and Day 43 | GMTs on Day 1 (prior to the first vaccination), Day 22 (3 weeks after the first vaccination), and Day 43 (3 weeks after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses. |
| Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | Day 1 (baseline), Day 22, and Day 43 | GMRs calculated as follows: Day 22/Day 1 and Day 43/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses. |
| Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | Day 1 (baseline), Day 22, and Day 43 | Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 22 and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses. |
| Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Day 1 through Day 7 and Day 22 through Day 28 | Percentages of subjects with solicited local and systemic AEs that occurred within 7 days following each vaccination, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses. |
| Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Day 1 through Day 43 | Percentages of subjects with any unsolicited AEs reported within 21 days after each vaccination within each vaccine group, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | Day 1 (baseline) and Day 202 | GMRs calculated as follows: Day 202/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. |
| Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | Day 1 (baseline) and Day 202 | Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. |
| Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | Day 1 (baseline) and Day 202 | Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1 and Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. |
| Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | Day 1 (baseline) and Day 202 | GMTs on Day 1 (prior to the first vaccination) and Day 202 (6 months after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. |
Countries
Estonia, Philippines
Participant flow
Recruitment details
Subjects were enrolled from 2 centers in Estonia and 5 centers in the Philippines.
Pre-assignment details
In total, 420 subjects were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine 2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22) | 69 |
| Low Dose, Less Adjuvant aH5N1 Vaccine 2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22) | 72 |
| Mid Dose, Less Adjuvant aH5N1 Vaccine 2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22) | 70 |
| Lowest Dose, Adjuvanted aH5N1 Vaccine 2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22) | 70 |
| Low Dose, Adjuvanted aH5N1 Vaccine 2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22) | 69 |
| Mid Dose, Adjuvanted aH5N1 Vaccine 2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22) | 70 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Lowest Dose, Less Adjuvant aH5N1 Vaccine | Low Dose, Less Adjuvant aH5N1 Vaccine | Mid Dose, Less Adjuvant aH5N1 Vaccine | Lowest Dose, Adjuvanted aH5N1 Vaccine | Low Dose, Adjuvanted aH5N1 Vaccine | Mid Dose, Adjuvanted aH5N1 Vaccine | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 69 Participants | 72 Participants | 70 Participants | 70 Participants | 69 Participants | 70 Participants | 420 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 48.2 months STANDARD_DEVIATION 28.8 | 50.9 months STANDARD_DEVIATION 31.61 | 47.1 months STANDARD_DEVIATION 30.9 | 48.8 months STANDARD_DEVIATION 31.81 | 49.9 months STANDARD_DEVIATION 30.79 | 50.6 months STANDARD_DEVIATION 31.77 | 49.3 months STANDARD_DEVIATION 30.82 |
| Age, Customized 3 years to <9 years | 34 Participants | 37 Participants | 35 Participants | 35 Participants | 33 Participants | 36 Participants | 210 Participants |
| Age, Customized 6 months to <36 months | 35 Participants | 35 Participants | 35 Participants | 35 Participants | 36 Participants | 34 Participants | 210 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 72 Participants | 70 Participants | 70 Participants | 69 Participants | 70 Participants | 420 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 52 Participants | 56 Participants | 53 Participants | 53 Participants | 52 Participants | 53 Participants | 319 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 16 Participants | 17 Participants | 17 Participants | 17 Participants | 16 Participants | 100 Participants |
| Received an influenza vaccination in the past 2 years No | 68 Participants | 72 Participants | 67 Participants | 67 Participants | 66 Participants | 68 Participants | 408 Participants |
| Received an influenza vaccination in the past 2 years Yes | 1 Participants | 0 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 12 Participants |
| Region of Enrollment Estonia | 17 participants | 16 participants | 17 participants | 17 participants | 17 participants | 16 participants | 100 participants |
| Region of Enrollment Philippines | 52 participants | 56 participants | 53 participants | 53 participants | 52 participants | 54 participants | 320 participants |
| Sex: Female, Male Female | 31 Participants | 26 Participants | 33 Participants | 31 Participants | 31 Participants | 40 Participants | 192 Participants |
| Sex: Female, Male Male | 38 Participants | 46 Participants | 37 Participants | 39 Participants | 38 Participants | 30 Participants | 228 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 / 69 | 1 / 72 | 0 / 70 | 0 / 70 | 0 / 69 | 0 / 70 |
| other Total, other adverse events | 37 / 69 | 34 / 72 | 40 / 70 | 39 / 70 | 37 / 69 | 33 / 70 |
| serious Total, serious adverse events | 0 / 69 | 1 / 72 | 3 / 70 | 0 / 70 | 1 / 69 | 3 / 70 |
Outcome results
Primary
Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain
GMTs on Day 1 (prior to the first vaccination), Day 22 (3 weeks after the first vaccination), and Day 43 (3 weeks after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Time frame: Day 1 (baseline), Day 22, and Day 43
Population: Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.19 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (overall study population) | 5.61 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (3 years to <9 years age cohort) | 70.21 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (3 years to <9 years age cohort) | 5.61 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (3 years to <9 years age cohort) | 33.70 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.38 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (overall study population) | 81.10 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.05 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (6 months to <36 months age cohort) | 618.77 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.10 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (6 months to <36 months age cohort) | 29.27 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (6 months to <36 months age cohort) | 5.59 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (3 years to <9 years age cohort) | 458.11 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (overall study population) | 531.04 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (6 months to <36 months age cohort) | 93.22 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (overall study population) | 31.42 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (overall study population) | 667.86 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (3 years to <9 years age cohort) | 48.35 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (3 years to <9 years age cohort) | 6.32 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (3 years to <9 years age cohort) | 36.69 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (overall study population) | 6.21 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (3 years to <9 years age cohort) | 495.77 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.54 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (overall study population) | 34.83 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.27 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (overall study population) | 68.06 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (6 months to <36 months age cohort) | 6.14 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (6 months to <36 months age cohort) | 910.32 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (6 months to <36 months age cohort) | 98.37 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (6 months to <36 months age cohort) | 33.14 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (6 months to <36 months age cohort) | 5.51 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (overall study population) | 5.98 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (overall study population) | 86.70 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.42 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.21 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (6 months to <36 months age cohort) | 102.28 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (3 years to <9 years age cohort) | 6.29 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (3 years to <9 years age cohort) | 69.40 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.38 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (overall study population) | 40.61 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (overall study population) | 610.37 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.26 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (6 months to <36 months age cohort) | 24.93 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (6 months to <36 months age cohort) | 717.83 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.49 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (3 years to <9 years age cohort) | 66.97 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (3 years to <9 years age cohort) | 518.46 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (6 months to <36 months age cohort) | 725.06 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (6 months to <36 months age cohort) | 129.72 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.21 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.16 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (overall study population) | 122.43 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.11 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (6 months to <36 months age cohort) | 45.78 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.05 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (overall study population) | 46.08 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (3 years to <9 years age cohort) | 46.59 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (3 years to <9 years age cohort) | 6.10 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (overall study population) | 6.17 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (6 months to <36 months age cohort) | 6.23 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.11 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (overall study population) | 619.44 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (3 years to <9 years age cohort) | 114.85 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (3 years to <9 years age cohort) | 527.09 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (6 months to <36 months age cohort) | 6.55 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (6 months to <36 months age cohort) | 157.44 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.13 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (3 years to <9 years age cohort) | 42.11 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (overall study population) | 54.66 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (overall study population) | 864.91 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.00 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.10 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (6 months to <36 months age cohort) | 69.41 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (overall study population) | 123.37 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (6 months to <36 months age cohort) | 1094.07 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (overall study population) | 6.47 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.16 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (3 years to <9 years age cohort) | 6.42 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (3 years to <9 years age cohort) | 680.71 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (3 years to <9 years age cohort) | 97.17 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (overall study population) | 5.78 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.31 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (overall study population) | 766.18 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (3 years to <9 years age cohort) | 65.11 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (6 months to <36 months age cohort) | 5.78 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.35 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (6 months to <36 months age cohort) | 120.07 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.45 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.24 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (overall study population) | 123.61 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (overall study population) | 52.81 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 22 (6 months to <36 months age cohort) | 42.07 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 43 (3 years to <9 years age cohort) | 129.15 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.29 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (3 years to <9 years age cohort) | 670.67 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | HI GMT Day 22 (3 years to <9 years age cohort) | 5.91 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain | MN GMT Day 43 (6 months to <36 months age cohort) | 863.94 titer |
Primary
Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMRs calculated as follows: Day 22/Day 1 and Day 43/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Time frame: Day 1 (baseline), Day 22, and Day 43
Population: PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (6 months to <36 months age cohort) | 5.76 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (overall study population) | 6.02 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (overall study population) | 16.14 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (overall study population) | 102.26 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (3 years to <9 years age cohort) | 85.22 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (6 months to <36 months age cohort) | 1.10 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (3 years to <9 years age cohort) | 6.29 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (6 months to <36 months age cohort) | 18.27 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (overall study population) | 1.11 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (3 years to <9 years age cohort) | 1.12 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (6 months to <36 months age cohort) | 122.81 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (3 years to <9 years age cohort) | 14.27 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (6 months to <36 months age cohort) | 180.68 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (3 years to <9 years age cohort) | 89.57 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (overall study population) | 6.62 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (6 months to <36 months age cohort) | 6.52 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (3 years to <9 years age cohort) | 1.26 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (6 months to <36 months age cohort) | 19.62 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (overall study population) | 126.71 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (6 months to <36 months age cohort) | 1.21 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (overall study population) | 13.77 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (3 years to <9 years age cohort) | 9.83 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (overall study population) | 1.24 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (3 years to <9 years age cohort) | 6.73 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (3 years to <9 years age cohort) | 94.64 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (6 months to <36 months age cohort) | 1.05 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (overall study population) | 1.15 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (6 months to <36 months age cohort) | 4.80 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (6 months to <36 months age cohort) | 19.02 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (6 months to <36 months age cohort) | 137.36 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (3 years to <9 years age cohort) | 14.10 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (overall study population) | 7.66 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (overall study population) | 113.98 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (3 years to <9 years age cohort) | 1.26 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (overall study population) | 16.38 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (3 years to <9 years age cohort) | 12.37 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (6 months to <36 months age cohort) | 139.62 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (overall study population) | 1.22 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (overall study population) | 24.35 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (6 months to <36 months age cohort) | 1.22 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (6 months to <36 months age cohort) | 25.41 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (3 years to <9 years age cohort) | 1.22 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (3 years to <9 years age cohort) | 23.34 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (overall study population) | 8.85 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (overall study population) | 119.78 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (6 months to <36 months age cohort) | 8.84 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (3 years to <9 years age cohort) | 8.90 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (3 years to <9 years age cohort) | 102.76 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (3 years to <9 years age cohort) | 1.29 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (6 months to <36 months age cohort) | 1.30 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (6 months to <36 months age cohort) | 13.54 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (3 years to <9 years age cohort) | 131.50 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (3 years to <9 years age cohort) | 8.00 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (6 months to <36 months age cohort) | 31.39 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (overall study population) | 24.98 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (6 months to <36 months age cohort) | 214.16 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (3 years to <9 years age cohort) | 19.75 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (overall study population) | 10.52 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (overall study population) | 1.29 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (overall study population) | 168.06 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (6 months to <36 months age cohort) | 1.14 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (3 years to <9 years age cohort) | 21.98 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (3 years to <9 years age cohort) | 1.08 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (3 years to <9 years age cohort) | 125.44 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (6 months to <36 months age cohort) | 8.09 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (6 months to <36 months age cohort) | 23.94 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (6 months to <36 months age cohort) | 164.74 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 43/Day 1 (overall study population) | 144.55 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 43/Day 1 (overall study population) | 23.14 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (3 years to <9 years age cohort) | 12.18 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 22/Day 1 (overall study population) | 1.11 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 22/Day 1 (overall study population) | 10.02 ratio |
Primary
Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 22 and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Time frame: Day 1 (baseline), Day 22, and Day 43
Population: PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (overall study population) | 44.8 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (overall study population) | 82.1 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (3 years to <9 years age cohort) | 84.8 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (3 years to <9 years age cohort) | 54.5 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (6 months to <36 months age cohort) | 35.3 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (overall study population) | 100.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (6 months to <36 months age cohort) | 79.4 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (6 months to <36 months age cohort) | 55.9 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (3 years to <9 years age cohort) | 5.4 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (overall study population) | 56.5 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (3 years to <9 years age cohort) | 67.6 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (6 months to <36 months age cohort) | 2.9 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (overall study population) | 4.2 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (3 years to <9 years age cohort) | 57.1 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (6 months to <36 months age cohort) | 82.4 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (overall study population) | 74.6 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (overall study population) | 100.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (3 years to <9 years age cohort) | 6.1 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (overall study population) | 3.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (overall study population) | 77.6 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (6 months to <36 months age cohort) | 79.4 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (3 years to <9 years age cohort) | 75.8 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (overall study population) | 58.2 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (overall study population) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (6 months to <36 months age cohort) | 35.3 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (3 years to <9 years age cohort) | 81.8 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (overall study population) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (6 months to <36 months age cohort) | 3.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (3 years to <9 years age cohort) | 6.1 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (6 months to <36 months age cohort) | 71.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (overall study population) | 4.5 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (6 months to <36 months age cohort) | 93.9 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (3 years to <9 years age cohort) | 87.9 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (overall study population) | 90.9 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (3 years to <9 years age cohort) | 63.6 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (overall study population) | 67.2 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (overall study population) | 1.4 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (3 years to <9 years age cohort) | 62.5 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (overall study population) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (3 years to <9 years age cohort) | 3.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (3 years to <9 years age cohort) | 87.9 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (overall study population) | 72.7 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (6 months to <36 months age cohort) | 86.1 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (6 months to <36 months age cohort) | 82.4 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (overall study population) | 87.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (6 months to <36 months age cohort) | 58.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (6 months to <36 months age cohort) | 87.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (overall study population) | 68.7 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (6 months to <36 months age cohort) | 3.2 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (overall study population) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (overall study population) | 86.6 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 43 (3 years to <9 years age cohort) | 86.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (overall study population) | 3.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 22 (3 years to <9 years age cohort) | 77.8 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 22 (3 years to <9 years age cohort) | 2.8 percentage of participants |
Primary
Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1, Day 22, and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Time frame: Day 1 (baseline), Day 22, and Day 43
Population: PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 54.5 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (overall study population) | 44.8 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 79.4 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 35.3 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (overall study population) | 100.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (overall study population) | 82.1 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 84.8 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (overall study population) | 4.2 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (overall study population) | 100.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (overall study population) | 56.5 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (overall study population) | 74.6 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 57.1 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 2.9 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 82.4 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 55.9 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 5.4 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 67.6 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 75.8 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (overall study population) | 77.6 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (overall study population) | 3.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 35.3 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (overall study population) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 81.8 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (overall study population) | 58.2 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 6.1 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 79.4 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (overall study population) | 4.5 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (overall study population) | 90.9 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 3.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 93.9 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 6.1 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 87.9 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (overall study population) | 67.2 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (overall study population) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 71.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 63.6 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 82.4 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 87.9 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 3.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (overall study population) | 87.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 86.1 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 62.5 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (overall study population) | 1.4 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (overall study population) | 72.7 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (overall study population) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (overall study population) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 2.8 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 2.8 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 1.5 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 58.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 87.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (6 months to <36 months age cohort) | 3.2 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (overall study population) | 86.6 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 22 (overall study population) | 3.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (overall study population) | 68.7 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 22 (3 years to <9 years age cohort) | 77.8 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 43 (3 years to <9 years age cohort) | 86.1 percentage of participants |
Primary
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Percentages of subjects with solicited local and systemic AEs that occurred within 7 days following each vaccination, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Time frame: Day 1 through Day 7 and Day 22 through Day 28
Population: Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data collected, including temperature measurements or use of analgesics/antipyretics.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (6 months to <36 months age cohort) | 7 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (overall study population) | 9 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (6 months to <36 years age cohort) | 15 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (3 years to <9 years age cohort) | 4 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (3 years to <9 years age cohort) | 7 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (overall study population) | 32 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (3 years to <9 years age cohort) | 12 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (3 years to <9 years age cohort) | 17 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (overall study population) | 19 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (6 months to <36 months age cohort) | 5 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (overall study population) | 21 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (6 months to <36 months age cohort) | 14 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (6 months to <36 months age cohort) | 10 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (overall study population) | 24 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (overall study population) | 7 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (overall study population) | 33 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (6 months to <36 years age cohort) | 20 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (overall study population) | 16 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (3 years to <9 years age cohort) | 9 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (6 months to <36 months age cohort) | 4 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (3 years to <9 years age cohort) | 6 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (3 years to <9 years age cohort) | 3 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (6 months to <36 months age cohort) | 15 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (3 years to <9 years age cohort) | 13 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (overall study population) | 6 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (overall study population) | 32 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (3 years to <9 years age cohort) | 4 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (3 years to <9 years age cohort) | 2 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (overall study population) | 16 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (overall study population) | 20 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (6 months to <36 years age cohort) | 18 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (6 months to <36 months age cohort) | 6 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (6 months to <36 months age cohort) | 16 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (6 months to <36 months age cohort) | 4 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (3 years to <9 years age cohort) | 14 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (3 years to <9 years age cohort) | 10 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (overall study population) | 34 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (3 years to <9 years age cohort) | 10 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (6 months to <36 months age cohort) | 16 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (overall study population) | 5 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (3 years to <9 years age cohort) | 2 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (6 months to <36 months age cohort) | 11 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (overall study population) | 21 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (6 months to <36 months age cohort) | 3 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (overall study population) | 24 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (6 months to <36 years age cohort) | 20 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (3 years to <9 years age cohort) | 14 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (3 years to <9 years age cohort) | 8 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (overall study population) | 19 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (3 years to <9 years age cohort) | 11 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (3 years to <9 years age cohort) | 2 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (3 years to <9 years age cohort) | 16 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (3 years to <9 years age cohort) | 11 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (6 months to <36 months age cohort) | 8 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (6 months to <36 months age cohort) | 18 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (overall study population) | 5 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (overall study population) | 37 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (6 months to <36 months age cohort) | 3 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (6 months to <36 years age cohort) | 21 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (overall study population) | 29 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (6 months to <36 years age cohort) | 15 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (6 months to <36 months age cohort) | 4 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (overall study population) | 17 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (6 months to <36 months age cohort) | 11 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (3 years to <9 years age cohort) | 7 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (6 months to <36 months age cohort) | 6 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (overall study population) | 31 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs (3 years to <9 years age cohort) | 16 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (3 years to <9 years age cohort) | 3 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs (3 years to <9 years age cohort) | 13 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/antipyretic use (overall study population) | 9 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs (overall study population) | 18 Participants |
Primary
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Percentages of subjects with any unsolicited AEs reported within 21 days after each vaccination within each vaccine group, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Time frame: Day 1 through Day 43
Population: Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (6 months to <36 months age cohort) | 1 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (overall study population) | 2 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (3 years to <9 years age cohort) | 6 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (3 years to <9 years age cohort) | 1 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (3 years to <9 years age cohort) | 6 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (overall study population) | 18 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (6 months to <36 months age cohort) | 12 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (overall study population) | 18 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (6 months to <36 months age cohort) | 12 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (6 months to <36 months age cohort) | 11 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (overall study population) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (overall study population) | 15 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (6 months to <36 months age cohort) | 2 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (6 months to <36 months age cohort) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (overall study population) | 2 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (3 years to <9 years age cohort) | 4 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (overall study population) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (overall study population) | 14 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (6 months to <36 months age cohort) | 10 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (3 years to <9 years age cohort) | 4 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (3 years to <9 years age cohort) | 7 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (overall study population) | 20 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (3 years to <9 years age cohort) | 7 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (6 months to <36 months age cohort) | 13 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (overall study population) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (overall study population) | 20 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (overall study population) | 2 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (6 months to <36 months age cohort) | 13 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (overall study population) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (6 months to <36 months age cohort) | 2 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (3 years to <9 years age cohort) | 2 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (3 years to <9 years age cohort) | 2 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (overall study population) | 10 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (overall study population) | 10 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (6 months to <36 months age cohort) | 8 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (6 months to <36 months age cohort) | 8 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (overall study population) | 12 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (3 years to <9 years age cohort) | 2 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (overall study population) | 15 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (overall study population) | 2 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (6 months to <36 months age cohort) | 1 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (3 years to <9 years age cohort) | 1 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (3 years to <9 years age cohort) | 5 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (3 years to <9 years age cohort) | 7 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (6 months to <36 months age cohort) | 1 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (6 months to <36 months age cohort) | 7 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (overall study population) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (6 months to <36 months age cohort) | 8 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (overall study population) | 3 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (overall study population) | 1 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (overall study population) | 9 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (overall study population) | 12 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (6 months to <36 months age cohort) | 7 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (3 years to <9 years age cohort) | 1 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Related (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (6 months to <36 months age cohort) | 5 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (3 years to <9 years age cohort) | 1 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Mild (3 years to <9 years age cohort) | 4 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (6 months to <36 months age cohort) | 2 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Any (3 years to <9 years age cohort) | 5 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Severe (overall study population) | 1 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs | Unsolicited AEs, Moderate (overall study population) | 2 Participants |
Primary
Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal
Percentages of subjects reporting SAEs, NOCDs, AESIs, and AEs leading to vaccine and/or study withdrawal, as collected from Day 1 through Day 387, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Time frame: Day 1 through Day 387
Population: Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (overall study population) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (3 years to <9 years age cohort) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (overall study population) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (overall study population) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (overall study population) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (overall study population) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (overall study population) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (6 months to <36 months age cohort) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (6 months to <36 months age cohort) | 1 Participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (overall study population) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (3 years to <9 years age cohort) | 2 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (overall study population) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (overall study population) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (overall study population) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (overall study population) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (6 months to <36 months age cohort) | 1 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (overall study population) | 3 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (6 months to <36 months age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (overall study population) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (3 years to <9 years age cohort) | 0 Participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (6 months to <36 months age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (3 years to <9 years age cohort) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (overall study population) | 1 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (overall study population) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (overall study population) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (overall study population) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (overall study population) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (overall study population) | 0 Participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (6 months to <36 months age cohort) | 1 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (overall study population) | 3 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (6 months to <36 months age cohort) | 2 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (overall study population) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | SAE (3 years to <9 years age cohort) | 1 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AE leading to withdrawal (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (6 months to <36 months age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (3 years to <9 years age cohort) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | NOCD (overall study population) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Death (overall study population) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | AESI (overall study population) | 0 Participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal | Related SAE (overall study population) | 0 Participants |
Secondary
Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMTs on Day 1 (prior to the first vaccination) and Day 202 (6 months after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Time frame: Day 1 (baseline) and Day 202
Population: PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (overall study population) | 7.92 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (overall study population) | 113.24 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.05 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (3 years to <9 years age cohort) | 89.38 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.10 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.38 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (6 months to <36 months age cohort) | 9.11 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (6 months to <36 months age cohort) | 144.60 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (3 years to <9 years age cohort) | 6.90 titer |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.19 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.27 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (3 years to <9 years age cohort) | 6.36 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (6 months to <36 months age cohort) | 12.57 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (overall study population) | 146.98 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (overall study population) | 8.90 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.00 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.54 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (3 years to <9 years age cohort) | 101.19 titer |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (6 months to <36 months age cohort) | 217.84 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.49 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.42 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (6 months to <36 months age cohort) | 11.60 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.21 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (6 months to <36 months age cohort) | 175.31 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (3 years to <9 years age cohort) | 6.55 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.38 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (overall study population) | 146.41 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (overall study population) | 8.81 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (3 years to <9 years age cohort) | 122.19 titer |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.26 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (overall study population) | 10.19 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.05 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.11 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (6 months to <36 months age cohort) | 13.55 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (3 years to <9 years age cohort) | 7.66 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.16 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (overall study population) | 150.56 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.21 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (6 months to <36 months age cohort) | 174.21 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.11 titer |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (3 years to <9 years age cohort) | 129.11 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.00 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.00 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (3 years to <9 years age cohort) | 136.08 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.16 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (6 months to <36 months age cohort) | 19.12 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (overall study population) | 12.90 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.10 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.13 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (6 months to <36 months age cohort) | 245.52 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (overall study population) | 183.15 titer |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (3 years to <9 years age cohort) | 8.69 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (overall study population) | 195.57 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (3 years to <9 years age cohort) | 5.45 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (6 months to <36 months age cohort) | 5.29 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (6 months to <36 months age cohort) | 19.00 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (3 years to <9 years age cohort) | 142.59 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 202 (6 months to <36 months age cohort) | 268.31 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (6 months to <36 months age cohort) | 5.00 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (overall study population) | 13.15 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (3 years to <9 years age cohort) | 5.35 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMT Day 1 (overall study population) | 5.31 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 1 (overall study population) | 5.24 titer |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMT Day 202 (3 years to <9 years age cohort) | 9.30 titer |
Secondary
Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMRs calculated as follows: Day 202/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Time frame: Day 1 (baseline) and Day 202
Population: PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (3 years to <9 years age cohort) | 1.38 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (6 months to <36 months age cohort) | 1.79 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (3 years to <9 years age cohort) | 16.64 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (6 months to <36 months age cohort) | 28.49 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (overall study population) | 1.57 ratio |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (overall study population) | 21.77 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (overall study population) | 1.78 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (3 years to <9 years age cohort) | 1.28 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (6 months to <36 months age cohort) | 42.91 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (6 months to <36 months age cohort) | 2.50 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (3 years to <9 years age cohort) | 18.41 ratio |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (overall study population) | 27.94 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (3 years to <9 years age cohort) | 1.31 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (3 years to <9 years age cohort) | 22.38 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (6 months to <36 months age cohort) | 2.17 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (overall study population) | 1.69 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (overall study population) | 27.45 ratio |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (6 months to <36 months age cohort) | 33.76 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (6 months to <36 months age cohort) | 33.68 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (overall study population) | 29.04 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (3 years to <9 years age cohort) | 25.04 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (6 months to <36 months age cohort) | 2.65 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (3 years to <9 years age cohort) | 1.54 ratio |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (overall study population) | 2.02 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (3 years to <9 years age cohort) | 1.74 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (6 months to <36 months age cohort) | 3.81 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (overall study population) | 35.47 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (overall study population) | 2.59 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (3 years to <9 years age cohort) | 26.18 ratio |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (6 months to <36 months age cohort) | 47.95 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (3 years to <9 years age cohort) | 26.63 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (6 months to <36 months age cohort) | 51.56 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (overall study population) | 2.50 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (6 months to <36 months age cohort) | 3.78 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | HI GMR Day 202/Day 1 (3 years to <9 years age cohort) | 1.68 ratio |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain | MN GMR Day 202/Day 1 (overall study population) | 36.95 ratio |
Secondary
Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Time frame: Day 1 (baseline) and Day 202
Population: PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (overall study population) | 10.4 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (3 years to <9 years age cohort) | 3.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (3 years to <9 years age cohort) | 93.9 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (6 months to <36 months age cohort) | 97.1 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (6 months to <36 months age cohort) | 17.6 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (overall study population) | 95.5 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (overall study population) | 14.1 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (overall study population) | 97.2 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (3 years to <9 years age cohort) | 2.7 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (6 months to <36 months age cohort) | 26.5 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (3 years to <9 years age cohort) | 94.6 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (overall study population) | 11.9 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (6 months to <36 months age cohort) | 23.5 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (overall study population) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (6 months to <36 months age cohort) | 27.3 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (3 years to <9 years age cohort) | 97.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (overall study population) | 15.2 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (6 months to <36 months age cohort) | 97.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (3 years to <9 years age cohort) | 3.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (overall study population) | 97.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (3 years to <9 years age cohort) | 9.1 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (6 months to <36 months age cohort) | 33.3 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (overall study population) | 98.6 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (overall study population) | 21.7 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (3 years to <9 years age cohort) | 97.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (3 years to <9 years age cohort) | 94.3 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (overall study population) | 25.4 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (6 months to <36 months age cohort) | 41.9 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | HI seroconversion at Day 202 (3 years to <9 years age cohort) | 11.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (overall study population) | 97.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer) | MN seroconversion at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
Secondary
Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1 and Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Time frame: Day 1 (baseline) and Day 202
Population: PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.~Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 17.6 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 93.9 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (overall study population) | 10.4 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 3.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 97.1 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (overall study population) | 95.5 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 97.3 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (overall study population) | 14.1 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 26.5 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 2.7 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Low Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (overall study population) | 98.6 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 23.5 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (overall study population) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 100.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (overall study population) | 11.9 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Less Adjuvant aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 97.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 27.3 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (overall study population) | 97.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 3.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (overall study population) | 15.2 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Lowest Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 97.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 33.3 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (overall study population) | 21.7 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 9.1 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (overall study population) | 98.6 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Low Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 97.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 100.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (overall study population) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 11.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 2.8 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (6 months to <36 months age cohort) | 41.9 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (3 years to <9 years age cohort) | 97.1 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 202 (overall study population) | 25.4 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort) | 0.0 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | MN titer ≥1:40 at Day 202 (overall study population) | 98.5 percentage of participants |
| Mid Dose, Adjuvanted aH5N1 Vaccine | Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40 | HI titer ≥1:40 at Day 1 (overall study population) | 1.5 percentage of participants |