Trial Outcomes & Findings for A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults (NCT NCT05901636)
NCT ID: NCT05901636
Last Updated: 2025-09-08
Results Overview
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Results posted on
2025-09-08
Participant Flow
Study consisted of 2 Cohorts: Cohort 1 (Group 1 to 3) and Cohort 2 (Group 4 to 8). Participants were enrolled in a staggered approach with safety evaluations (Day 8) in place before extending enrollment in each cohort and progressing from one cohort to the next. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Participant milestones
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
Participants received a single dose of 45 micrograms (mcg) Influenza A Group 1 (G1) hemagglutinin stem-derived protein antigen (mHA) vaccine as intramuscular (IM) injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
Participants received a single dose of 45 mcg Influenza A G1 mHA with Aluminum Hydroxide (Al\[OH\]3) vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
25
|
25
|
20
|
|
Overall Study
Number of Participants Who Received Vaccination 1
|
25
|
25
|
25
|
25
|
25
|
25
|
20
|
|
Overall Study
Number of Participants Who Received Vaccination 2
|
24
|
23
|
23
|
25
|
23
|
24
|
20
|
|
Overall Study
Number of Participants Who Received 2 Doses of Placebo in Group 3
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
|
Overall Study
Number of Participants Who Received 2 Doses of Placebo in Group 8
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
|
Overall Study
COMPLETED
|
24
|
23
|
22
|
22
|
23
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
3
|
2
|
4
|
3
|
Reasons for withdrawal
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
Participants received a single dose of 45 micrograms (mcg) Influenza A Group 1 (G1) hemagglutinin stem-derived protein antigen (mHA) vaccine as intramuscular (IM) injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
Participants received a single dose of 45 mcg Influenza A G1 mHA with Aluminum Hydroxide (Al\[OH\]3) vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
1
|
3
|
1
|
|
Overall Study
Non- Compliance With Study Schedule
|
0
|
0
|
2
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.6 Years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
31.2 Years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
34.3 Years
STANDARD_DEVIATION 7.13 • n=5 Participants
|
35.1 Years
STANDARD_DEVIATION 7.22 • n=4 Participants
|
32.0 Years
STANDARD_DEVIATION 7.06 • n=21 Participants
|
32.5 Years
STANDARD_DEVIATION 7.96 • n=10 Participants
|
31.6 Years
STANDARD_DEVIATION 7.69 • n=115 Participants
|
32.7 Years
STANDARD_DEVIATION 7.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
89 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
81 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
68 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
102 Participants
n=24 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
|
0 Participants
n=24 Participants
|
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
38 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
129 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 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
|
2 Participants
n=24 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
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
170 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)Population: Full analysis set (FAS) included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1
|
5 Participants
|
12 Participants
|
3 Participants
|
13 Participants
|
6 Participants
|
14 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2
|
5 Participants
|
9 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using food and drug administration (FDA) toxicity grading scale- Pain: Grade (G) 1 (mild; does not interfere with activity); G2 (moderate; requires modification in activity/use of medications); G3 (severe; inability to do usual activities/use of narcotic pain reliever); G4 (life threatening; hospitalization), Erythema and swelling: G 1 (mild; 25 -50 millimeter \[mm\]); G2 (moderate; 51 -100 mm); G3 (severe; greater than \[\>\] 100 mm); G4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using FDA toxicity grading scale- Pain: Grade 1 (mild; does not interfere with activity); Grade 2 (moderate; requires modification in activity/use of medications); Grade 3 (severe; inability to do usual activities/use of narcotic pain reliever); Grade 4 (life threatening; hospitalization), Erythema and swelling: Grade 1 (mild; 25 -50 mm); Grade 2 (moderate; 51 -100 mm); Grade 3 (severe; \>100 mm); Grade 4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 365Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=5 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=12 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=3 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=13 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=6 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=14 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=1 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1
Vaccination site erythema
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
—
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
|
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1
Vaccination site swelling
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
5.0 Days
Interval 5.0 to 5.0
|
—
|
—
|
—
|
—
|
|
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1
Vaccination site pain
|
1.0 Days
Interval 1.0 to 2.0
|
2.5 Days
Interval 1.0 to 7.0
|
4.0 Days
Interval 3.0 to 5.0
|
2.0 Days
Interval 1.0 to 4.0
|
1.0 Days
Interval 1.0 to 1.0
|
2.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: From Day 57 up to Day 365Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=5 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=9 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=5 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=8 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=2 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=5 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=2 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2
Vaccination site erythema
|
—
|
—
|
—
|
—
|
—
|
—
|
1.0 Days
Interval 1.0 to 1.0
|
|
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2
Vaccination site swelling
|
—
|
—
|
—
|
—
|
—
|
—
|
1.0 Days
Interval 1.0 to 1.0
|
|
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2
Vaccination site pain
|
1.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 6.0
|
2.0 Days
Interval 1.0 to 4.0
|
1.5 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1
|
7 Participants
|
12 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
12 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2
|
4 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius \[C\]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (\>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius \[C\]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (\>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 365Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=7 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=12 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=6 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=9 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=7 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=12 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=4 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1
Fatigue
|
2.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 6.0
|
1.5 Days
Interval 1.0 to 3.0
|
1 Days
Interval 1.0 to 1.0
|
1.5 Days
Interval 1.0 to 5.0
|
4.5 Days
Interval 1.0 to 8.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1
Headache
|
3.0 Days
Interval 2.0 to 4.0
|
4.0 Days
Interval 1.0 to 6.0
|
1.5 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 1.0
|
5.5 Days
Interval 4.0 to 7.0
|
4.5 Days
Interval 1.0 to 6.0
|
—
|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1
Nausea
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
1.0 Days
Interval 1.0 to 1.0
|
5.0 Days
Interval 2.0 to 7.0
|
—
|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1
Myalgia
|
1.0 Days
Interval 1.0 to 2.0
|
3.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 2.0
|
3.5 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: From Day 57 up to Day 365Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=4 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=8 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=7 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=9 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=6 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=8 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=4 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Fatigue
|
6.0 Days
Interval 2.0 to 15.0
|
6.0 Days
Interval 4.0 to 8.0
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 9.0
|
1.0 Days
Interval 1.0 to 4.0
|
4.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Headache
|
9.0 Days
Interval 1.0 to 17.0
|
5.0 Days
Interval 1.0 to 8.0
|
3.0 Days
Interval 2.0 to 6.0
|
3.0 Days
Interval 2.0 to 7.0
|
2.0 Days
Interval 2.0 to 2.0
|
4.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 2.0 to 2.0
|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Nausea
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
—
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
3.5 Days
Interval 1.0 to 6.0
|
1.5 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Myalgia
|
1.5 Days
Interval 1.0 to 2.0
|
2.5 Days
Interval 1.0 to 5.0
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
1.0 Days
Interval 1.0 to 6.0
|
—
|
|
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Pyrexia
|
—
|
—
|
—
|
—
|
—
|
—
|
8.0 Days
Interval 8.0 to 8.0
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1
|
7 Participants
|
12 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
12 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2
|
4 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 365Population: FAS: all participants with at least 1 vaccination documented. N=number of participants evaluable for this outcome measure; n (number analyzed)=number of participants evaluable for specified rows. N=0 indicated that data was not collected and analyzed as no participant experienced any AE in specified arm. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 1 are reported below.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=1 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=1 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=1 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=1 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=1 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Anaemia
|
—
|
—
|
—
|
—
|
—
|
—
|
57.0 Days
Interval 57.0 to 57.0
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Dermatitis contact
|
—
|
—
|
—
|
—
|
—
|
11.0 Days
Interval 11.0 to 11.0
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Diarrhoea
|
—
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Nasopharyngitis
|
11.0 Days
Interval 11.0 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Ventricular extrasystoles
|
—
|
—
|
—
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 57 up to Day 365Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicates that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 2 are reported below.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=1 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=1 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=2 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=3 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=2 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=2 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=1 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Anaemia
|
—
|
—
|
—
|
—
|
34.0 Days
Interval 34.0 to 34.0
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Arthralgia
|
—
|
3.0 Days
Interval 3.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Blood pressure increased
|
—
|
—
|
—
|
20.0 Days
Interval 20.0 to 20.0
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Gastroenteritis
|
—
|
—
|
—
|
7.0 Days
Interval 7.0 to 7.0
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Hypertension
|
—
|
—
|
—
|
252.0 Days
Interval 252.0 to 252.0
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Influenza like illness
|
—
|
—
|
6.0 Days
Interval 6.0 to 6.0
|
7.0 Days
Interval 7.0 to 7.0
|
4.0 Days
Interval 4.0 to 4.0
|
7.0 Days
Interval 7.0 to 7.0
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Leukopenia
|
—
|
—
|
52.0 Days
Interval 52.0 to 52.0
|
—
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Nephrolithiasis
|
14.0 Days
Interval 14.0 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Otitis media acute
|
—
|
—
|
—
|
7.0 Days
Interval 7.0 to 7.0
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Pulmonary embolism
|
—
|
—
|
—
|
—
|
—
|
—
|
92.0 Days
Interval 92.0 to 92.0
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Rhinorrhoea
|
—
|
—
|
—
|
2.0 Days
Interval 2.0 to 2.0
|
—
|
—
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Sinusitis
|
—
|
—
|
—
|
—
|
—
|
8.0 Days
Interval 8.0 to 8.0
|
—
|
|
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Transient ischaemic attack
|
—
|
—
|
—
|
3.0 Days
Interval 3.0 to 3.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)Population: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=23 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=23 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=24 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first vaccination (Day 1) up to Day 365Population: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with SAEs and SAEs related to study vaccine were reported.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine
SAE related to study vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 29 and 85Population: PPI included all randomized and vaccinated participants for whom immunogenicity data were available excluding samples taken on or after the date when a participant experiences a major protocol deviation expected to impact the immunogenicity outcomes. 'n' (number analyzed)=number of participants evaluable for specified rows. n=0 indicates that no participant was available for the analysis in the respective arm for specified category.
Geometric mean concentration of antibodies binding to HA stem or full-length HA protein as measured by ELISA (H5-ELISA and mHA ELISA) was reported. HA stem derived protein vaccine antigen (mHA) derived from H1N1 A/California/07/2009 virus strain. Per-protocol Immunogenicity population was denoted as PPI. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Outcome measures
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=24 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 Participants
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 Participants
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
H5 A/Vietnam/1203/2004 ELISA: Day 29
|
2919 ELISA Unit per milliliter (EU)/mL
Interval 1563.0 to 5450.0
|
2990 ELISA Unit per milliliter (EU)/mL
Interval 1970.0 to 4538.0
|
3240 ELISA Unit per milliliter (EU)/mL
Interval 1750.0 to 5998.0
|
4468 ELISA Unit per milliliter (EU)/mL
Interval 2659.0 to 7507.0
|
3998 ELISA Unit per milliliter (EU)/mL
Interval 2262.0 to 7068.0
|
5468 ELISA Unit per milliliter (EU)/mL
Interval 3429.0 to 8717.0
|
329 ELISA Unit per milliliter (EU)/mL
Interval 197.0 to 549.0
|
|
Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
H5 A/Vietnam/1203/2004 ELISA: Day 85
|
3015 ELISA Unit per milliliter (EU)/mL
Interval 1738.0 to 5233.0
|
2892 ELISA Unit per milliliter (EU)/mL
Interval 1879.0 to 4450.0
|
3413 ELISA Unit per milliliter (EU)/mL
Interval 1984.0 to 5870.0
|
4276 ELISA Unit per milliliter (EU)/mL
Interval 2755.0 to 6638.0
|
3044 ELISA Unit per milliliter (EU)/mL
Interval 1774.0 to 5224.0
|
3087 ELISA Unit per milliliter (EU)/mL
Interval 1955.0 to 4874.0
|
363 ELISA Unit per milliliter (EU)/mL
Interval 228.0 to 578.0
|
|
Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
H1 mHA A/California/07/2009 ELISA: Day 29
|
27285 ELISA Unit per milliliter (EU)/mL
Interval 16056.0 to 46368.0
|
28343 ELISA Unit per milliliter (EU)/mL
Interval 20284.0 to 39604.0
|
31894 ELISA Unit per milliliter (EU)/mL
Interval 17465.0 to 58242.0
|
43631 ELISA Unit per milliliter (EU)/mL
Interval 28230.0 to 67437.0
|
44575 ELISA Unit per milliliter (EU)/mL
Interval 28632.0 to 69397.0
|
57306 ELISA Unit per milliliter (EU)/mL
Interval 41346.0 to 79426.0
|
3337 ELISA Unit per milliliter (EU)/mL
Interval 2109.0 to 5280.0
|
|
Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
H1 mHA A/California/07/2009 ELISA: Day 85
|
28875 ELISA Unit per milliliter (EU)/mL
Interval 18668.0 to 44665.0
|
29496 ELISA Unit per milliliter (EU)/mL
Interval 21477.0 to 40509.0
|
36459 ELISA Unit per milliliter (EU)/mL
Interval 23450.0 to 56686.0
|
45667 ELISA Unit per milliliter (EU)/mL
Interval 33342.0 to 62547.0
|
31845 ELISA Unit per milliliter (EU)/mL
Interval 20601.0 to 49224.0
|
32809 ELISA Unit per milliliter (EU)/mL
Interval 24239.0 to 44409.0
|
3383 ELISA Unit per milliliter (EU)/mL
Interval 2136.0 to 5358.0
|
Adverse Events
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 3 and Group 8: Placebo (Two Doses)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 participants at risk
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 participants at risk
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 participants at risk
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
Other adverse events
| Measure |
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)
n=25 participants at risk
Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)
n=25 participants at risk
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)
n=25 participants at risk
Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
Group 3 and Group 8: Placebo (Two Doses)
n=20 participants at risk
Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
5.0%
1/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
12.0%
3/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
8.0%
2/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
8.0%
2/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
16.0%
4/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
12.0%
3/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
10.0%
2/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
General disorders
Fatigue (Solicited)
|
32.0%
8/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
32.0%
8/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
28.0%
7/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
40.0%
10/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
28.0%
7/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
32.0%
8/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
25.0%
5/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
General disorders
Pyrexia (Solicited)
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
5.0%
1/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
General disorders
Vaccination Site Erythema (Solicited)
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
8.0%
2/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
5.0%
1/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
General disorders
Vaccination Site Pain (Solicited)
|
28.0%
7/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
52.0%
13/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
20.0%
5/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
56.0%
14/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
28.0%
7/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
60.0%
15/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
15.0%
3/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
General disorders
Vaccination Site Swelling (Solicited)
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
8.0%
2/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
4.0%
1/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
5.0%
1/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
20.0%
5/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
40.0%
10/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
16.0%
4/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
20.0%
5/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
8.0%
2/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
40.0%
10/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
5.0%
1/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
Nervous system disorders
Headache (Solicited)
|
12.0%
3/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
28.0%
7/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
20.0%
5/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
24.0%
6/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
12.0%
3/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
36.0%
9/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
5.0%
1/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
0.00%
0/25 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
5.0%
1/20 • All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER