Trial Outcomes & Findings for A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine (NCT NCT04669691)
NCT ID: NCT04669691
Last Updated: 2024-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
420 participants
Primary outcome timeframe
Day 1 through Day 7 and Day 22 through Day 28
Results posted on
2024-03-13
Participant Flow
Subjects were enrolled from 2 centers in Estonia and 5 centers in the Philippines.
In total, 420 subjects were enrolled in the study.
Participant milestones
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
72
|
70
|
70
|
69
|
70
|
|
Overall Study
COMPLETED
|
69
|
71
|
70
|
70
|
69
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=69 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=72 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
53 Participants
n=10 Participants
|
319 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
<=18 years
|
69 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
420 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
48.2 months
STANDARD_DEVIATION 28.80 • n=5 Participants
|
50.9 months
STANDARD_DEVIATION 31.61 • n=7 Participants
|
47.1 months
STANDARD_DEVIATION 30.90 • n=5 Participants
|
48.8 months
STANDARD_DEVIATION 31.81 • n=4 Participants
|
49.9 months
STANDARD_DEVIATION 30.79 • n=21 Participants
|
50.6 months
STANDARD_DEVIATION 31.77 • n=10 Participants
|
49.3 months
STANDARD_DEVIATION 30.82 • n=115 Participants
|
|
Age, Customized
6 months to <36 months
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
210 Participants
n=115 Participants
|
|
Age, Customized
3 years to <9 years
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
210 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
192 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
228 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
420 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
100 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
Philippines
|
52 participants
n=5 Participants
|
56 participants
n=7 Participants
|
53 participants
n=5 Participants
|
53 participants
n=4 Participants
|
52 participants
n=21 Participants
|
54 participants
n=10 Participants
|
320 participants
n=115 Participants
|
|
Region of Enrollment
Estonia
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
17 participants
n=4 Participants
|
17 participants
n=21 Participants
|
16 participants
n=10 Participants
|
100 participants
n=115 Participants
|
|
Received an influenza vaccination in the past 2 years
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Received an influenza vaccination in the past 2 years
No
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
68 Participants
n=10 Participants
|
408 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7 and Day 22 through Day 28Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=69 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=72 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
|
15 Participants
|
16 Participants
|
16 Participants
|
18 Participants
|
11 Participants
|
|
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
|
9 Participants
|
4 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
|
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited AEs (overall study population)
|
32 Participants
|
33 Participants
|
32 Participants
|
34 Participants
|
37 Participants
|
31 Participants
|
|
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited Local AEs (overall study population)
|
19 Participants
|
16 Participants
|
16 Participants
|
21 Participants
|
19 Participants
|
17 Participants
|
|
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited Systemic AEs (overall study population)
|
21 Participants
|
24 Participants
|
20 Participants
|
24 Participants
|
29 Participants
|
18 Participants
|
|
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Analgesic/antipyretic use (overall study population)
|
9 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
|
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
|
20 Participants
|
18 Participants
|
20 Participants
|
21 Participants
|
15 Participants
|
|
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
|
10 Participants
|
6 Participants
|
11 Participants
|
8 Participants
|
4 Participants
|
|
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
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
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
|
13 Participants
|
14 Participants
|
14 Participants
|
16 Participants
|
16 Participants
|
|
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
|
6 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
13 Participants
|
|
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
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 43Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=69 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=72 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Severe (6 months to <36 months age cohort)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Related (6 months to <36 months age cohort)
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Any (overall study population)
|
18 Participants
|
15 Participants
|
20 Participants
|
10 Participants
|
15 Participants
|
12 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Mild (overall study population)
|
18 Participants
|
14 Participants
|
20 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Moderate (overall study population)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Severe (overall study population)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Related (overall study population)
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Any (6 months to <36 months age cohort)
|
12 Participants
|
11 Participants
|
13 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Mild (6 months to <36 months age cohort)
|
12 Participants
|
10 Participants
|
13 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Moderate (6 months to <36 months age cohort)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Any (3 years to <9 years age cohort)
|
6 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Mild (3 years to <9 years age cohort)
|
6 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Moderate (3 years to <9 years age cohort)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Severe (3 years to <9 years age cohort)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Unsolicited AEs, Related (3 years to <9 years age cohort)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 387Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=69 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=72 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=70 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (baseline), Day 22, and Day 43Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 4.8 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.21 titer
Interval 5.0 to 5.4
|
5.05 titer
Interval 4.8 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.24 titer
Interval 5.0 to 5.5
|
|
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
Interval 4.9 to 6.4
|
6.21 titer
Interval 5.5 to 7.0
|
5.98 titer
Interval 5.3 to 6.8
|
6.17 titer
Interval 5.4 to 7.0
|
6.47 titer
Interval 5.7 to 7.3
|
5.78 titer
Interval 5.1 to 6.6
|
|
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
Interval 58.3 to 112.8
|
68.06 titer
Interval 49.4 to 93.8
|
86.70 titer
Interval 62.3 to 120.7
|
122.43 titer
Interval 87.8 to 170.7
|
123.37 titer
Interval 89.1 to 170.8
|
123.61 titer
Interval 88.8 to 172.1
|
|
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
Interval 4.7 to 6.6
|
6.14 titer
Interval 5.2 to 7.3
|
5.51 titer
Interval 4.6 to 6.6
|
6.23 titer
Interval 5.2 to 7.4
|
6.55 titer
Interval 5.5 to 7.8
|
5.78 titer
Interval 4.8 to 6.9
|
|
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
Interval 56.5 to 153.7
|
98.37 titer
Interval 59.6 to 162.4
|
102.28 titer
Interval 61.5 to 170.1
|
129.72 titer
Interval 78.1 to 215.5
|
157.44 titer
Interval 96.7 to 256.3
|
120.07 titer
Interval 71.0 to 202.9
|
|
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
Interval 4.9 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.42 titer
Interval 5.2 to 5.7
|
5.11 titer
Interval 4.9 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.00 titer
Interval 4.8 to 5.2
|
|
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
Interval 4.6 to 5.4
|
5.00 titer
Interval 4.7 to 5.4
|
5.00 titer
Interval 4.6 to 5.4
|
5.00 titer
Interval 4.6 to 5.4
|
5.00 titer
Interval 4.6 to 5.4
|
5.45 titer
Interval 5.1 to 5.9
|
|
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
Interval 4.6 to 6.8
|
6.32 titer
Interval 5.3 to 7.6
|
6.29 titer
Interval 5.2 to 7.6
|
6.10 titer
Interval 5.0 to 7.4
|
6.42 titer
Interval 5.3 to 7.8
|
5.91 titer
Interval 4.9 to 7.1
|
|
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
Interval 45.5 to 108.4
|
48.35 titer
Interval 32.1 to 72.9
|
69.40 titer
Interval 44.9 to 107.2
|
114.85 titer
Interval 74.4 to 177.4
|
97.17 titer
Interval 62.9 to 150.1
|
129.15 titer
Interval 84.9 to 196.6
|
|
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
Interval 4.9 to 5.5
|
5.27 titer
Interval 5.0 to 5.6
|
5.38 titer
Interval 5.1 to 5.7
|
5.16 titer
Interval 4.9 to 5.5
|
5.13 titer
Interval 4.9 to 5.4
|
5.31 titer
Interval 5.0 to 5.6
|
|
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
Interval 24.7 to 40.0
|
34.83 titer
Interval 27.5 to 44.2
|
40.61 titer
Interval 31.9 to 51.7
|
46.08 titer
Interval 36.0 to 59.0
|
54.66 titer
Interval 42.9 to 69.7
|
52.81 titer
Interval 41.5 to 67.2
|
|
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
Interval 424.7 to 664.1
|
667.86 titer
Interval 536.7 to 831.1
|
610.37 titer
Interval 488.0 to 763.4
|
619.44 titer
Interval 494.5 to 775.9
|
864.91 titer
Interval 693.8 to 1078.2
|
766.18 titer
Interval 612.6 to 958.2
|
|
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
Interval 4.7 to 5.3
|
5.00 titer
Interval 4.7 to 5.3
|
5.26 titer
Interval 4.9 to 5.6
|
5.21 titer
Interval 4.9 to 5.6
|
5.10 titer
Interval 4.8 to 5.4
|
5.29 titer
Interval 4.9 to 5.7
|
|
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
Interval 24.0 to 47.4
|
36.69 titer
Interval 26.3 to 51.1
|
66.97 titer
Interval 47.6 to 94.2
|
46.59 titer
Interval 33.1 to 65.6
|
42.11 titer
Interval 29.8 to 59.6
|
65.11 titer
Interval 47.0 to 90.2
|
|
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
Interval 448.2 to 854.3
|
910.32 titer
Interval 659.3 to 1256.9
|
717.83 titer
Interval 520.0 to 991.0
|
725.06 titer
Interval 522.8 to 1005.5
|
1094.07 titer
Interval 800.0 to 1496.2
|
863.94 titer
Interval 616.3 to 1211.2
|
|
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
Interval 4.9 to 5.9
|
5.54 titer
Interval 5.1 to 6.0
|
5.49 titer
Interval 5.0 to 6.0
|
5.11 titer
Interval 4.7 to 5.6
|
5.16 titer
Interval 4.7 to 5.7
|
5.35 titer
Interval 4.9 to 5.8
|
|
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
Interval 21.0 to 40.8
|
33.14 titer
Interval 23.8 to 46.2
|
24.93 titer
Interval 17.9 to 34.7
|
45.78 titer
Interval 32.3 to 64.8
|
69.41 titer
Interval 49.8 to 96.7
|
42.07 titer
Interval 29.7 to 59.6
|
|
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
Interval 334.2 to 627.9
|
495.77 titer
Interval 366.4 to 670.9
|
518.46 titer
Interval 378.2 to 710.8
|
527.09 titer
Interval 384.3 to 723.0
|
680.71 titer
Interval 496.4 to 933.4
|
670.67 titer
Interval 495.9 to 907.0
|
PRIMARY outcome
Timeframe: Day 1 (baseline), Day 22, and Day 43Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 1.0 to 1.3
|
1.24 ratio
Interval 1.1 to 1.4
|
1.15 ratio
Interval 1.0 to 1.3
|
1.22 ratio
Interval 1.1 to 1.4
|
1.29 ratio
Interval 1.1 to 1.5
|
1.11 ratio
Interval 1.0 to 1.3
|
|
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
Interval 11.5 to 22.6
|
13.77 ratio
Interval 9.9 to 19.1
|
16.38 ratio
Interval 11.7 to 23.0
|
24.35 ratio
Interval 17.3 to 34.2
|
24.98 ratio
Interval 17.9 to 34.8
|
23.14 ratio
Interval 16.5 to 32.4
|
|
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
Interval 0.9 to 1.4
|
1.26 ratio
Interval 1.0 to 1.5
|
1.26 ratio
Interval 1.0 to 1.5
|
1.22 ratio
Interval 1.0 to 1.5
|
1.29 ratio
Interval 1.0 to 1.6
|
1.08 ratio
Interval 0.9 to 1.3
|
|
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
Interval 9.0 to 22.6
|
9.83 ratio
Interval 6.4 to 15.2
|
14.10 ratio
Interval 8.9 to 22.3
|
23.34 ratio
Interval 14.7 to 37.0
|
19.75 ratio
Interval 12.5 to 31.3
|
21.98 ratio
Interval 14.2 to 34.1
|
|
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
Interval 61.6 to 118.0
|
89.57 ratio
Interval 65.6 to 122.3
|
94.64 ratio
Interval 68.4 to 131.0
|
102.76 ratio
Interval 74.2 to 142.3
|
131.50 ratio
Interval 95.0 to 182.0
|
125.44 ratio
Interval 91.9 to 171.3
|
|
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
Interval 11.1 to 30.1
|
19.62 ratio
Interval 11.9 to 32.4
|
19.02 ratio
Interval 11.5 to 31.4
|
25.41 ratio
Interval 15.3 to 42.2
|
31.39 ratio
Interval 19.3 to 51.1
|
23.94 ratio
Interval 14.2 to 40.4
|
|
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
Interval 4.7 to 7.7
|
6.62 ratio
Interval 5.2 to 8.4
|
7.66 ratio
Interval 6.0 to 9.8
|
8.85 ratio
Interval 6.9 to 11.3
|
10.52 ratio
Interval 8.2 to 13.4
|
10.02 ratio
Interval 7.9 to 12.8
|
|
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
Interval 81.4 to 128.5
|
126.71 ratio
Interval 101.4 to 158.4
|
113.98 ratio
Interval 90.7 to 143.2
|
119.78 ratio
Interval 95.2 to 150.7
|
168.06 ratio
Interval 134.2 to 210.5
|
144.55 ratio
Interval 115.0 to 181.6
|
|
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
Interval 4.1 to 8.0
|
6.52 ratio
Interval 4.7 to 9.1
|
4.80 ratio
Interval 3.4 to 6.7
|
8.84 ratio
Interval 6.2 to 12.5
|
13.54 ratio
Interval 9.7 to 18.9
|
8.09 ratio
Interval 5.7 to 11.4
|
|
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
Interval 88.8 to 169.9
|
180.68 ratio
Interval 130.6 to 250.0
|
137.36 ratio
Interval 99.3 to 190.0
|
139.62 ratio
Interval 100.4 to 194.1
|
214.16 ratio
Interval 156.2 to 293.6
|
164.74 ratio
Interval 117.3 to 231.4
|
|
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
Interval 4.5 to 8.9
|
6.73 ratio
Interval 4.8 to 9.4
|
12.37 ratio
Interval 8.8 to 17.4
|
8.90 ratio
Interval 6.3 to 12.5
|
8.00 ratio
Interval 5.7 to 11.3
|
12.18 ratio
Interval 8.8 to 16.9
|
|
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
Interval 0.9 to 1.3
|
1.21 ratio
Interval 1.0 to 1.4
|
1.05 ratio
Interval 0.9 to 1.3
|
1.22 ratio
Interval 1.0 to 1.5
|
1.30 ratio
Interval 1.1 to 1.5
|
1.14 ratio
Interval 1.0 to 1.4
|
PRIMARY outcome
Timeframe: Day 1 (baseline), Day 22, and Day 43Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 0.0 to 5.36
|
4.2 percentage of participants
Interval 0.88 to 11.86
|
3.0 percentage of participants
Interval 0.36 to 10.37
|
4.5 percentage of participants
Interval 0.95 to 12.71
|
1.4 percentage of participants
Interval 0.04 to 7.81
|
3.0 percentage of participants
Interval 0.36 to 10.37
|
|
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
Interval 0.0 to 10.28
|
2.9 percentage of participants
Interval 0.07 to 15.33
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
3.0 percentage of participants
Interval 0.08 to 15.76
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
3.2 percentage of participants
Interval 0.08 to 16.7
|
|
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
Interval 62.1 to 91.3
|
82.4 percentage of participants
Interval 65.47 to 93.24
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
93.9 percentage of participants
Interval 79.77 to 99.26
|
86.1 percentage of participants
Interval 70.5 to 95.33
|
87.1 percentage of participants
Interval 70.17 to 96.37
|
|
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
Interval 0.0 to 10.58
|
5.4 percentage of participants
Interval 0.66 to 18.19
|
6.1 percentage of participants
Interval 0.74 to 20.23
|
6.1 percentage of participants
Interval 0.74 to 20.23
|
3.0 percentage of participants
Interval 0.08 to 15.76
|
2.8 percentage of participants
Interval 0.07 to 14.53
|
|
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
Interval 68.1 to 94.89
|
67.6 percentage of participants
Interval 50.21 to 81.99
|
75.8 percentage of participants
Interval 57.74 to 88.91
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
86.1 percentage of participants
Interval 70.5 to 95.33
|
|
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
Interval 32.6 to 57.42
|
56.5 percentage of participants
Interval 44.04 to 68.42
|
58.2 percentage of participants
Interval 45.52 to 70.15
|
67.2 percentage of participants
Interval 54.31 to 78.41
|
72.7 percentage of participants
Interval 60.36 to 82.97
|
68.7 percentage of participants
Interval 56.16 to 79.44
|
|
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
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
|
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
Interval 94.64 to 100.0
|
100.0 percentage of participants
Interval 94.87 to 100.0
|
100.0 percentage of participants
Interval 94.64 to 100.0
|
100.0 percentage of participants
Interval 94.56 to 100.0
|
100.0 percentage of participants
Interval 94.79 to 100.0
|
100.0 percentage of participants
Interval 94.64 to 100.0
|
|
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
Interval 70.8 to 90.39
|
74.6 percentage of participants
Interval 62.92 to 84.23
|
77.6 percentage of participants
Interval 65.78 to 86.89
|
90.9 percentage of participants
Interval 81.26 to 96.59
|
87.0 percentage of participants
Interval 76.68 to 93.86
|
86.6 percentage of participants
Interval 76.03 to 93.67
|
|
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
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
100.0 percentage of participants
Interval 88.78 to 100.0
|
|
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
Interval 36.35 to 71.89
|
57.1 percentage of participants
Interval 39.35 to 73.68
|
81.8 percentage of participants
Interval 64.54 to 93.02
|
63.6 percentage of participants
Interval 45.12 to 79.6
|
62.5 percentage of participants
Interval 43.69 to 78.9
|
77.8 percentage of participants
Interval 60.85 to 89.88
|
|
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
Interval 19.75 to 53.51
|
55.9 percentage of participants
Interval 37.89 to 72.81
|
35.3 percentage of participants
Interval 19.75 to 53.51
|
71.0 percentage of participants
Interval 51.96 to 85.78
|
82.4 percentage of participants
Interval 65.47 to 93.24
|
58.1 percentage of participants
Interval 39.08 to 75.45
|
PRIMARY outcome
Timeframe: Day 1 (baseline), Day 22, and Day 43Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.06
|
0.0 percentage of participants
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.44
|
0.0 percentage of participants
Interval 0.0 to 5.21
|
1.5 percentage of participants
Interval 0.04 to 8.04
|
|
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
Interval 0.0 to 5.36
|
4.2 percentage of participants
Interval 0.88 to 11.86
|
3.0 percentage of participants
Interval 0.36 to 10.37
|
4.5 percentage of participants
Interval 0.95 to 12.71
|
1.4 percentage of participants
Interval 0.04 to 7.81
|
3.0 percentage of participants
Interval 0.36 to 10.37
|
|
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
Interval 70.8 to 90.39
|
74.6 percentage of participants
Interval 62.92 to 84.23
|
77.6 percentage of participants
Interval 65.78 to 86.89
|
90.9 percentage of participants
Interval 81.26 to 96.59
|
87.0 percentage of participants
Interval 76.68 to 93.86
|
86.6 percentage of participants
Interval 76.03 to 93.67
|
|
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
Interval 0.0 to 10.58
|
5.4 percentage of participants
Interval 0.66 to 18.19
|
6.1 percentage of participants
Interval 0.74 to 20.23
|
6.1 percentage of participants
Interval 0.74 to 20.23
|
3.0 percentage of participants
Interval 0.08 to 15.76
|
2.8 percentage of participants
Interval 0.07 to 14.53
|
|
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
Interval 32.6 to 57.42
|
56.5 percentage of participants
Interval 44.04 to 68.42
|
58.2 percentage of participants
Interval 45.52 to 70.15
|
67.2 percentage of participants
Interval 54.31 to 78.41
|
72.7 percentage of participants
Interval 60.36 to 82.97
|
68.7 percentage of participants
Interval 56.16 to 79.44
|
|
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
Interval 94.64 to 100.0
|
100.0 percentage of participants
Interval 94.87 to 100.0
|
100.0 percentage of participants
Interval 94.64 to 100.0
|
100.0 percentage of participants
Interval 94.56 to 100.0
|
100.0 percentage of participants
Interval 94.79 to 100.0
|
100.0 percentage of participants
Interval 94.64 to 100.0
|
|
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
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
0.0 percentage of participants
Interval 0.0 to 11.22
|
|
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
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
0.0 percentage of participants
Interval 0.0 to 11.22
|
|
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
Interval 0.0 to 10.28
|
2.9 percentage of participants
Interval 0.07 to 15.33
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
3.0 percentage of participants
Interval 0.08 to 15.76
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
3.2 percentage of participants
Interval 0.08 to 16.7
|
|
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
Interval 62.1 to 91.3
|
82.4 percentage of participants
Interval 65.47 to 93.24
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
93.9 percentage of participants
Interval 79.77 to 99.26
|
86.1 percentage of participants
Interval 70.5 to 95.33
|
87.1 percentage of participants
Interval 70.17 to 96.37
|
|
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
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.49
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
2.8 percentage of participants
Interval 0.07 to 14.53
|
|
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
Interval 68.1 to 94.89
|
67.6 percentage of participants
Interval 50.21 to 81.99
|
75.8 percentage of participants
Interval 57.74 to 88.91
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
86.1 percentage of participants
Interval 70.5 to 95.33
|
|
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
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.06
|
0.0 percentage of participants
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.44
|
0.0 percentage of participants
Interval 0.0 to 5.21
|
0.0 percentage of participants
Interval 0.0 to 5.36
|
|
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
Interval 19.75 to 53.51
|
55.9 percentage of participants
Interval 37.89 to 72.81
|
35.3 percentage of participants
Interval 19.75 to 53.51
|
71.0 percentage of participants
Interval 51.96 to 85.78
|
82.4 percentage of participants
Interval 65.47 to 93.24
|
58.1 percentage of participants
Interval 39.08 to 75.45
|
|
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
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
100.0 percentage of participants
Interval 88.78 to 100.0
|
|
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
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.49
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
|
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
Interval 36.35 to 71.89
|
57.1 percentage of participants
Interval 39.35 to 73.68
|
81.8 percentage of participants
Interval 64.54 to 93.02
|
63.6 percentage of participants
Interval 45.12 to 79.6
|
62.5 percentage of participants
Interval 43.69 to 78.9
|
77.8 percentage of participants
Interval 60.85 to 89.88
|
|
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
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 202Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 6.3 to 13.3
|
12.57 titer
Interval 8.6 to 18.3
|
11.60 titer
Interval 7.9 to 17.0
|
13.55 titer
Interval 9.3 to 19.8
|
19.12 titer
Interval 13.3 to 27.6
|
19.00 titer
Interval 12.8 to 28.2
|
|
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
Interval 4.8 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.21 titer
Interval 5.0 to 5.4
|
5.05 titer
Interval 4.8 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.24 titer
Interval 5.0 to 5.5
|
|
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
Interval 6.3 to 9.9
|
8.90 titer
Interval 7.2 to 11.0
|
8.81 titer
Interval 7.1 to 11.0
|
10.19 titer
Interval 8.2 to 12.7
|
12.90 titer
Interval 10.4 to 16.1
|
13.15 titer
Interval 10.5 to 16.4
|
|
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
Interval 4.9 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.42 titer
Interval 5.2 to 5.7
|
5.11 titer
Interval 4.9 to 5.3
|
5.00 titer
Interval 4.8 to 5.2
|
5.00 titer
Interval 4.8 to 5.2
|
|
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
Interval 4.6 to 5.4
|
5.00 titer
Interval 4.7 to 5.4
|
5.00 titer
Interval 4.6 to 5.4
|
5.00 titer
Interval 4.6 to 5.4
|
5.00 titer
Interval 4.6 to 5.4
|
5.45 titer
Interval 5.1 to 5.9
|
|
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
Interval 5.4 to 8.8
|
6.36 titer
Interval 5.1 to 8.0
|
6.55 titer
Interval 5.2 to 8.3
|
7.66 titer
Interval 6.0 to 9.7
|
8.69 titer
Interval 6.8 to 11.0
|
9.30 titer
Interval 7.4 to 11.7
|
|
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
Interval 4.9 to 5.5
|
5.27 titer
Interval 5.0 to 5.6
|
5.38 titer
Interval 5.1 to 5.7
|
5.16 titer
Interval 4.9 to 5.5
|
5.13 titer
Interval 4.9 to 5.4
|
5.31 titer
Interval 5.0 to 5.6
|
|
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
Interval 94.7 to 135.4
|
146.98 titer
Interval 123.6 to 174.8
|
146.41 titer
Interval 122.4 to 175.1
|
150.56 titer
Interval 125.7 to 180.3
|
183.15 titer
Interval 153.6 to 218.4
|
195.57 titer
Interval 163.3 to 234.2
|
|
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
Interval 4.7 to 5.3
|
5.00 titer
Interval 4.7 to 5.3
|
5.26 titer
Interval 4.9 to 5.6
|
5.21 titer
Interval 4.9 to 5.6
|
5.10 titer
Interval 4.8 to 5.4
|
5.29 titer
Interval 4.9 to 5.7
|
|
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
Interval 111.8 to 187.0
|
217.84 titer
Interval 168.4 to 281.7
|
175.31 titer
Interval 135.6 to 226.7
|
174.21 titer
Interval 134.2 to 226.1
|
245.52 titer
Interval 191.3 to 315.1
|
268.31 titer
Interval 205.0 to 351.3
|
|
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
Interval 4.9 to 5.9
|
5.54 titer
Interval 5.1 to 6.0
|
5.49 titer
Interval 5.0 to 6.0
|
5.11 titer
Interval 4.7 to 5.6
|
5.16 titer
Interval 4.7 to 5.7
|
5.35 titer
Interval 4.9 to 5.8
|
|
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
Interval 69.6 to 114.8
|
101.19 titer
Interval 79.8 to 128.2
|
122.19 titer
Interval 95.1 to 157.0
|
129.11 titer
Interval 100.4 to 165.9
|
136.08 titer
Interval 105.9 to 174.9
|
142.59 titer
Interval 111.8 to 181.8
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 202Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 1.3 to 2.0
|
1.78 ratio
Interval 1.4 to 2.2
|
1.69 ratio
Interval 1.3 to 2.1
|
2.02 ratio
Interval 1.6 to 2.5
|
2.59 ratio
Interval 2.1 to 3.2
|
2.50 ratio
Interval 2.0 to 3.1
|
|
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
Interval 1.2 to 2.6
|
2.50 ratio
Interval 1.7 to 3.6
|
2.17 ratio
Interval 1.5 to 3.2
|
2.65 ratio
Interval 1.8 to 3.9
|
3.81 ratio
Interval 2.6 to 5.5
|
3.78 ratio
Interval 2.5 to 5.6
|
|
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
Interval 1.1 to 1.8
|
1.28 ratio
Interval 1.0 to 1.6
|
1.31 ratio
Interval 1.0 to 1.7
|
1.54 ratio
Interval 1.2 to 2.0
|
1.74 ratio
Interval 1.4 to 2.2
|
1.68 ratio
Interval 1.3 to 2.1
|
|
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
Interval 18.1 to 26.1
|
27.94 ratio
Interval 23.4 to 33.4
|
27.45 ratio
Interval 22.9 to 33.0
|
29.04 ratio
Interval 24.2 to 34.9
|
35.47 ratio
Interval 29.6 to 42.5
|
36.95 ratio
Interval 30.7 to 44.4
|
|
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
Interval 22.0 to 36.9
|
42.91 ratio
Interval 33.2 to 55.5
|
33.76 ratio
Interval 26.1 to 43.7
|
33.68 ratio
Interval 25.9 to 43.7
|
47.95 ratio
Interval 37.3 to 61.6
|
51.56 ratio
Interval 39.4 to 67.5
|
|
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
Interval 12.8 to 21.6
|
18.41 ratio
Interval 14.4 to 23.5
|
22.38 ratio
Interval 17.3 to 29.0
|
25.04 ratio
Interval 19.3 to 32.5
|
26.18 ratio
Interval 20.2 to 34.0
|
26.63 ratio
Interval 20.7 to 34.3
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 202Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 4.3 to 20.35
|
14.1 percentage of participants
Interval 6.97 to 24.38
|
11.9 percentage of participants
Interval 5.3 to 22.18
|
15.2 percentage of participants
Interval 7.51 to 26.1
|
21.7 percentage of participants
Interval 12.71 to 33.31
|
25.4 percentage of participants
Interval 15.53 to 37.49
|
|
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
Interval 6.76 to 34.53
|
26.5 percentage of participants
Interval 12.88 to 44.36
|
23.5 percentage of participants
Interval 10.75 to 41.17
|
27.3 percentage of participants
Interval 13.3 to 45.52
|
33.3 percentage of participants
Interval 18.56 to 50.97
|
41.9 percentage of participants
Interval 24.55 to 60.92
|
|
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
Interval 0.08 to 15.76
|
2.7 percentage of participants
Interval 0.07 to 14.16
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
3.0 percentage of participants
Interval 0.08 to 15.76
|
9.1 percentage of participants
Interval 1.92 to 24.33
|
11.1 percentage of participants
Interval 3.11 to 26.06
|
|
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
Interval 87.47 to 99.07
|
97.2 percentage of participants
Interval 90.19 to 99.66
|
100.0 percentage of participants
Interval 94.64 to 100.0
|
97.0 percentage of participants
Interval 89.48 to 99.63
|
98.6 percentage of participants
Interval 92.19 to 99.96
|
97.0 percentage of participants
Interval 89.48 to 99.63
|
|
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
Interval 84.67 to 99.93
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
97.0 percentage of participants
Interval 84.24 to 99.92
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
100.0 percentage of participants
Interval 88.78 to 100.0
|
|
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
Interval 79.77 to 99.26
|
94.6 percentage of participants
Interval 81.81 to 99.34
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
97.0 percentage of participants
Interval 84.24 to 99.92
|
97.0 percentage of participants
Interval 84.24 to 99.92
|
94.3 percentage of participants
Interval 80.84 to 99.3
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 202Population: 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.
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.
Outcome measures
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=71 Participants
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=66 Participants
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 Participants
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=67 Participants
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
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
Interval 6.76 to 34.53
|
26.5 percentage of participants
Interval 12.88 to 44.36
|
23.5 percentage of participants
Interval 10.75 to 41.17
|
27.3 percentage of participants
Interval 13.3 to 45.52
|
33.3 percentage of participants
Interval 18.56 to 50.97
|
41.9 percentage of participants
Interval 24.55 to 60.92
|
|
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
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.49
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
2.8 percentage of participants
Interval 0.07 to 14.53
|
|
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
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.06
|
0.0 percentage of participants
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.44
|
0.0 percentage of participants
Interval 0.0 to 5.21
|
0.0 percentage of participants
Interval 0.0 to 5.36
|
|
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
Interval 87.47 to 99.07
|
98.6 percentage of participants
Interval 92.4 to 99.96
|
100.0 percentage of participants
Interval 94.64 to 100.0
|
97.0 percentage of participants
Interval 89.48 to 99.63
|
98.6 percentage of participants
Interval 92.19 to 99.96
|
98.5 percentage of participants
Interval 91.84 to 99.96
|
|
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
Interval 84.67 to 99.93
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
100.0 percentage of participants
Interval 89.72 to 100.0
|
97.0 percentage of participants
Interval 84.24 to 99.92
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
100.0 percentage of participants
Interval 88.78 to 100.0
|
|
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
Interval 4.3 to 20.35
|
14.1 percentage of participants
Interval 6.97 to 24.38
|
11.9 percentage of participants
Interval 5.3 to 22.18
|
15.2 percentage of participants
Interval 7.51 to 26.1
|
21.7 percentage of participants
Interval 12.71 to 33.31
|
25.4 percentage of participants
Interval 15.53 to 37.49
|
|
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
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
0.0 percentage of participants
Interval 0.0 to 11.22
|
|
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
Interval 0.08 to 15.76
|
2.7 percentage of participants
Interval 0.07 to 14.16
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
3.0 percentage of participants
Interval 0.08 to 15.76
|
9.1 percentage of participants
Interval 1.92 to 24.33
|
11.1 percentage of participants
Interval 3.11 to 26.06
|
|
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
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.06
|
0.0 percentage of participants
Interval 0.0 to 5.36
|
0.0 percentage of participants
Interval 0.0 to 5.44
|
0.0 percentage of participants
Interval 0.0 to 5.21
|
1.5 percentage of participants
Interval 0.04 to 8.04
|
|
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
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.28
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
0.0 percentage of participants
Interval 0.0 to 11.22
|
|
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
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.49
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 10.58
|
0.0 percentage of participants
Interval 0.0 to 9.74
|
|
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
Interval 79.77 to 99.26
|
97.3 percentage of participants
Interval 85.84 to 99.93
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
97.0 percentage of participants
Interval 84.24 to 99.92
|
97.0 percentage of participants
Interval 84.24 to 99.92
|
97.1 percentage of participants
Interval 85.08 to 99.93
|
Adverse Events
Lowest Dose, Less Adjuvant aH5N1 Vaccine
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Low Dose, Less Adjuvant aH5N1 Vaccine
Serious events: 1 serious events
Other events: 34 other events
Deaths: 1 deaths
Mid Dose, Less Adjuvant aH5N1 Vaccine
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Lowest Dose, Adjuvanted aH5N1 Vaccine
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Low Dose, Adjuvanted aH5N1 Vaccine
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Mid Dose, Adjuvanted aH5N1 Vaccine
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=69 participants at risk
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=72 participants at risk
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=70 participants at risk
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=70 participants at risk
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 participants at risk
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=70 participants at risk
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
Pneumonia
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
Septic shock
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.9%
2/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.9%
2/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
Other adverse events
| Measure |
Lowest Dose, Less Adjuvant aH5N1 Vaccine
n=69 participants at risk
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Less Adjuvant aH5N1 Vaccine
n=72 participants at risk
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Less Adjuvant aH5N1 Vaccine
n=70 participants at risk
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
|
Lowest Dose, Adjuvanted aH5N1 Vaccine
n=70 participants at risk
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Low Dose, Adjuvanted aH5N1 Vaccine
n=69 participants at risk
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
Mid Dose, Adjuvanted aH5N1 Vaccine
n=70 participants at risk
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.9%
2/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
6/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.6%
4/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
17.1%
12/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.2%
5/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.1%
5/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
Injection site erythema
|
5.8%
4/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
6.9%
5/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
10.0%
7/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.1%
5/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.2%
5/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
Injection site induration
|
4.3%
3/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.2%
3/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.1%
5/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.2%
5/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
Injection site tenderness or pain
|
30.4%
21/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
16.7%
12/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
24.3%
17/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
24.3%
17/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
27.5%
19/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
24.3%
17/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Metabolism and nutrition disorders
Change of eating habits
|
10.1%
7/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
11.1%
8/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.3%
3/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.7%
6/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Gastrointestinal disorders
Diarrhea
|
14.5%
10/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
16.7%
12/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
15.7%
11/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
14.3%
10/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.7%
6/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.6%
6/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
Fatigue
|
1.4%
1/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.8%
2/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.7%
6/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.3%
3/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
Fever (≥38.0°C)
|
11.6%
8/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
12.5%
9/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
10.0%
7/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
10.0%
7/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.9%
2/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.6%
6/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Nervous system disorders
Headache
|
4.3%
3/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.8%
2/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.9%
2/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.3%
3/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.3%
3/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Psychiatric disorders
Irritability
|
11.6%
8/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
12.5%
9/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.6%
6/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
14.5%
10/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
4/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Nervous system disorders
Sleepiness
|
13.0%
9/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.7%
7/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.1%
5/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.6%
6/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
11.6%
8/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.3%
3/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
3/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
6.9%
5/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.1%
5/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.6%
6/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.8%
4/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
1.4%
1/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
Other solicited AE
|
10.1%
7/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.7%
7/72 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.1%
5/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.3%
3/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.8%
4/69 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
10.0%
7/70 • SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place