Trial Outcomes & Findings for A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals (NCT NCT05472038)
NCT ID: NCT05472038
Last Updated: 2025-10-01
Results Overview
Local reactions were recorded by participants in an electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: greater than (\>) 2.0 to 5.0 centimeter (cm), moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as adverse events (AEs) in the case report form within 7 days after the study vaccination were also reported.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1453 participants
Primary outcome timeframe
From Day 1 to Day 7 after study vaccination
Results posted on
2025-10-01
Participant Flow
The study consisted of 4 cohorts. Cohort 1 and 4 had distinct participant groups and objectives. Where appropriate, and as per planned analyses, data is summarized and combined for Cohort 2 (C2) and Cohort 3 (C3) 30 micrograms (mcg) groups (G) per age category to provide sufficient power for the immunogenicity hypotheses for each of the age groups.
Study consisted of 4 cohorts. Cohort 1 and 4 had distinct participant groups and objectives, while cohorts are different, they are part of same study. Both arms (Cohort 2 Group 2 and Cohort 3 Group 1) and (Cohort 2 Group 4 and Cohort 3 Group 2) received the same treatment and are from the same age group. As mentioned in the Protocol Objective section, arms with the same treatment and age group will be combined to provide a more comprehensive summary, rather than being listed in separate columns.
Participant milestones
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (wild type \[WT\]/ omicron \[OMI\] BA.2) 30 micrograms (mcg) intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged more than (\>) 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4 /BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
104
|
102
|
108
|
314
|
110
|
306
|
102
|
62
|
62
|
60
|
60
|
63
|
|
Overall Study
COMPLETED
|
102
|
96
|
103
|
298
|
106
|
300
|
101
|
59
|
57
|
58
|
55
|
59
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
5
|
16
|
4
|
6
|
1
|
3
|
5
|
2
|
5
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (wild type \[WT\]/ omicron \[OMI\] BA.2) 30 micrograms (mcg) intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged more than (\>) 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4 /BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
3
|
9
|
2
|
2
|
1
|
0
|
1
|
0
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
6
|
1
|
3
|
0
|
2
|
3
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
Not vaccinated
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
Baseline characteristics by cohort
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
n=104 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/ OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=108 Participants
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=314 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
n=110 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=306 Participants
Participants aged \> 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=60 Participants
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=60 Participants
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/ BA.5] 30 mcg)
n=63 Participants
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Total
n=1453 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
108 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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
108 Participants
n=22 Participants
|
|
Age, Customized
Adults (18-64 years)
|
104 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
147 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
62 Participants
n=6 Participants
|
62 Participants
n=6 Participants
|
60 Participants
n=64 Participants
|
60 Participants
n=17 Participants
|
63 Participants
n=21 Participants
|
1145 Participants
n=22 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
157 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
197 Participants
n=22 Participants
|
|
Age, Customized
85 years and over
|
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
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
167 Participants
n=10 Participants
|
55 Participants
n=115 Participants
|
39 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
40 Participants
n=64 Participants
|
37 Participants
n=17 Participants
|
38 Participants
n=21 Participants
|
831 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
139 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
20 Participants
n=64 Participants
|
23 Participants
n=17 Participants
|
25 Participants
n=21 Participants
|
622 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
7 Participants
n=64 Participants
|
12 Participants
n=17 Participants
|
13 Participants
n=21 Participants
|
199 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
273 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
267 Participants
n=10 Participants
|
89 Participants
n=115 Participants
|
55 Participants
n=6 Participants
|
52 Participants
n=6 Participants
|
53 Participants
n=64 Participants
|
48 Participants
n=17 Participants
|
50 Participants
n=21 Participants
|
1244 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=22 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
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
11 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=21 Participants
|
114 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
155 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
243 Participants
n=10 Participants
|
92 Participants
n=115 Participants
|
49 Participants
n=6 Participants
|
40 Participants
n=6 Participants
|
43 Participants
n=64 Participants
|
53 Participants
n=17 Participants
|
52 Participants
n=21 Participants
|
1157 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
18 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Local reactions were recorded by participants in an electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: greater than (\>) 2.0 to 5.0 centimeter (cm), moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as adverse events (AEs) in the case report form within 7 days after the study vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=104 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Any
|
5.8 Percentage of participants
Interval 2.1 to 12.1
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Mild
|
3.8 Percentage of participants
Interval 1.1 to 9.6
|
3.9 Percentage of participants
Interval 1.1 to 9.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Moderate
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Severe
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Any
|
10.6 Percentage of participants
Interval 5.4 to 18.1
|
10.8 Percentage of participants
Interval 5.5 to 18.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Mild
|
6.7 Percentage of participants
Interval 2.7 to 13.4
|
4.9 Percentage of participants
Interval 1.6 to 11.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Moderate
|
2.9 Percentage of participants
Interval 0.6 to 8.2
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Severe
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Any
|
82.7 Percentage of participants
Interval 74.0 to 89.4
|
81.4 Percentage of participants
Interval 72.4 to 88.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Mild
|
67.3 Percentage of participants
Interval 57.4 to 76.2
|
62.7 Percentage of participants
Interval 52.6 to 72.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Moderate
|
15.4 Percentage of participants
Interval 9.1 to 23.8
|
18.6 Percentage of participants
Interval 11.6 to 27.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Systemic events were recorded by participants in an e-diary. Fever was oral temperature greater than or equal to (\>=) 38 degree Celsius (deg C) and categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=104 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: Any
|
1.9 Percentage of participants
Interval 0.2 to 6.8
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >=38.0 deg C to 38.4 deg C
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.4 deg C to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.9 deg C to 40.0 deg C
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
2.9 Percentage of participants
Interval 0.6 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Any
|
73.1 Percentage of participants
Interval 63.5 to 81.3
|
62.7 Percentage of participants
Interval 52.6 to 72.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Mild
|
37.5 Percentage of participants
Interval 28.2 to 47.5
|
27.5 Percentage of participants
Interval 19.1 to 37.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Moderate
|
34.6 Percentage of participants
Interval 25.6 to 44.6
|
34.3 Percentage of participants
Interval 25.2 to 44.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Severe
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Any
|
52.9 Percentage of participants
Interval 42.8 to 62.8
|
46.1 Percentage of participants
Interval 36.2 to 56.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Mild
|
29.8 Percentage of participants
Interval 21.2 to 39.6
|
22.5 Percentage of participants
Interval 14.9 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Moderate
|
21.2 Percentage of participants
Interval 13.8 to 30.3
|
22.5 Percentage of participants
Interval 14.9 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Severe
|
1.9 Percentage of participants
Interval 0.2 to 6.8
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Any
|
21.2 Percentage of participants
Interval 13.8 to 30.3
|
19.6 Percentage of participants
Interval 12.4 to 28.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Mild
|
10.6 Percentage of participants
Interval 5.4 to 18.1
|
7.8 Percentage of participants
Interval 3.4 to 14.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Moderate
|
10.6 Percentage of participants
Interval 5.4 to 18.1
|
11.8 Percentage of participants
Interval 6.2 to 19.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Any
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Mild
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Any
|
14.4 Percentage of participants
Interval 8.3 to 22.7
|
19.6 Percentage of participants
Interval 12.4 to 28.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Mild
|
13.5 Percentage of participants
Interval 7.6 to 21.6
|
14.7 Percentage of participants
Interval 8.5 to 23.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Moderate
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
3.9 Percentage of participants
Interval 1.1 to 9.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Any
|
35.6 Percentage of participants
Interval 26.4 to 45.6
|
38.2 Percentage of participants
Interval 28.8 to 48.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Mild
|
18.3 Percentage of participants
Interval 11.4 to 27.1
|
23.5 Percentage of participants
Interval 15.7 to 33.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Moderate
|
17.3 Percentage of participants
Interval 10.6 to 26.0
|
14.7 Percentage of participants
Interval 8.5 to 23.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Any
|
18.3 Percentage of participants
Interval 11.4 to 27.1
|
17.6 Percentage of participants
Interval 10.8 to 26.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Mild
|
7.7 Percentage of participants
Interval 3.4 to 14.6
|
11.8 Percentage of participants
Interval 6.2 to 19.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Moderate
|
10.6 Percentage of participants
Interval 5.4 to 18.1
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 1 month after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=104 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Adverse Events (AEs) From Study Vaccination Through 1 Month After Study Vaccination
|
8.7 Percentage of participants
Interval 4.0 to 15.8
|
12.7 Percentage of participants
Interval 7.0 to 20.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event, medical event was judged by investigator; required inpatient hospitalization or prolongation of existing hospitalization.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=104 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline (before study vaccination)Population: Evaluable immunogenicity population (EIP): randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
GMTs and the corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=30 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=29 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Geometric Mean Titer (GMT) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain Neutralizing Titers (NTs) at Baseline- Participants Without Evidence of Infection
Omicron BA.2
|
169.3 Titer
Interval 96.7 to 296.3
|
377.8 Titer
Interval 229.2 to 622.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Geometric Mean Titer (GMT) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain Neutralizing Titers (NTs) at Baseline- Participants Without Evidence of Infection
Omicron BA.1
|
103.3 Titer
Interval 60.4 to 176.6
|
209.5 Titer
Interval 147.2 to 298.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Geometric Mean Titer (GMT) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain Neutralizing Titers (NTs) at Baseline- Participants Without Evidence of Infection
Reference strain
|
892.0 Titer
Interval 526.5 to 1511.3
|
1544.2 Titer
Interval 993.8 to 2399.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline (before study vaccination)Population: EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed'' =participants evaluable for specified rows.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=103 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=98 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Omicron BA.1
|
652.7 Titer
Interval 448.9 to 949.0
|
818.7 Titer
Interval 595.9 to 1124.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Omicron BA.2
|
1269.1 Titer
Interval 854.7 to 1884.6
|
1527.5 Titer
Interval 1061.3 to 2198.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Reference strain
|
3469.8 Titer
Interval 2536.5 to 4746.7
|
3755.9 Titer
Interval 2896.8 to 4869.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP: randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure; ''Number Analyzed'' signifies participants evaluable for specified rows.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=30 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=29 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Omicron BA.2
|
2414.8 Titer
Interval 1508.5 to 3865.4
|
2768.5 Titer
Interval 1948.5 to 3933.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Omicron BA.1
|
1666.1 Titer
Interval 1085.8 to 2556.6
|
1993.8 Titer
Interval 1309.1 to 3036.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Reference strain
|
8268.9 Titer
Interval 5901.9 to 11585.1
|
7391.6 Titer
Interval 5117.5 to 10676.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed'' = participants evaluable for specified rows.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=103 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=98 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.2
|
6267.9 Titer
Interval 4766.0 to 8243.1
|
4984.2 Titer
Interval 3976.4 to 6247.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.1
|
3582.2 Titer
Interval 2813.7 to 4560.7
|
3571.8 Titer
Interval 2899.6 to 4399.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Reference strain
|
14342.3 Titer
Interval 11811.9 to 17414.9
|
11246.8 Titer
Interval 9395.1 to 13463.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 1 month after the study vaccinationPopulation: EIP: randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure; ''Number Analyzed'' signifies participants evaluable for specified rows.
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ in analysis.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=30 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=29 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants Without Evidence of Infection
Omicron BA.2
|
14.6 Fold rise
Interval 8.4 to 25.5
|
6.9 Fold rise
Interval 4.4 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants Without Evidence of Infection
Omicron BA.1
|
16.1 Fold rise
Interval 10.9 to 23.9
|
9.5 Fold rise
Interval 6.5 to 13.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants Without Evidence of Infection
Reference strain
|
9.3 Fold rise
Interval 5.9 to 14.6
|
4.8 Fold rise
Interval 3.1 to 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 1 month after the study vaccinationPopulation: EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed''= participants evaluable for specified rows.
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5\*LLOQ in analysis.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=103 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=98 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.2
|
5.0 Fold rise
Interval 3.6 to 6.8
|
3.2 Fold rise
Interval 2.3 to 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.1
|
5.5 Fold rise
Interval 4.3 to 7.1
|
4.4 Fold rise
Interval 3.4 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Reference strain
|
4.1 Fold rise
Interval 3.3 to 5.2
|
3.0 Fold rise
Interval 2.4 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP: randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure; ''Number Analyzed'' signifies participants evaluable for specified rows.
Seroresponse was defined as achieving \>= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>= 4\*LLOQ was considered a seroresponse.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=30 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=29 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Omicron BA.2
|
82.8 Percentage of participants
Interval 64.2 to 94.2
|
71.4 Percentage of participants
Interval 51.3 to 86.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Omicron BA.1
|
93.3 Percentage of participants
Interval 77.9 to 99.2
|
86.2 Percentage of participants
Interval 68.3 to 96.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Reference strain
|
73.3 Percentage of participants
Interval 54.1 to 87.7
|
51.7 Percentage of participants
Interval 32.5 to 70.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed'' = participants evaluable for specified rows.
Seroresponse was defined as achieving \>= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>= 4\*LLOQ was considered a seroresponse.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=103 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=98 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.2
|
53.5 Percentage of participants
Interval 43.3 to 63.5
|
40.9 Percentage of participants
Interval 30.8 to 51.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.1
|
58.3 Percentage of participants
Interval 48.1 to 67.9
|
49.0 Percentage of participants
Interval 38.7 to 59.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Reference strain
|
43.7 Percentage of participants
Interval 33.9 to 53.8
|
30.6 Percentage of participants
Interval 21.7 to 40.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable for the specified rows.
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=107 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=110 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=105 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Any
|
7.5 Percentage of participants
Interval 3.3 to 14.2
|
6.9 Percentage of participants
Interval 2.8 to 13.6
|
15.5 Percentage of participants
Interval 9.3 to 23.6
|
1.9 Percentage of participants
Interval 0.2 to 6.7
|
8.9 Percentage of participants
Interval 4.2 to 16.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Mild
|
5.6 Percentage of participants
Interval 2.1 to 11.8
|
4.9 Percentage of participants
Interval 1.6 to 11.1
|
6.4 Percentage of participants
Interval 2.6 to 12.7
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
5.0 Percentage of participants
Interval 1.6 to 11.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Moderate
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
9.1 Percentage of participants
Interval 4.4 to 16.1
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
4.0 Percentage of participants
Interval 1.1 to 9.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Any
|
70.1 Percentage of participants
Interval 60.5 to 78.6
|
79.4 Percentage of participants
Interval 70.3 to 86.8
|
93.6 Percentage of participants
Interval 87.3 to 97.4
|
56.2 Percentage of participants
Interval 46.2 to 65.9
|
70.6 Percentage of participants
Interval 60.7 to 79.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Mild
|
42.1 Percentage of participants
Interval 32.6 to 52.0
|
63.7 Percentage of participants
Interval 53.6 to 73.0
|
53.6 Percentage of participants
Interval 43.9 to 63.2
|
50.5 Percentage of participants
Interval 40.5 to 60.4
|
52.9 Percentage of participants
Interval 42.8 to 62.9
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Moderate
|
27.1 Percentage of participants
Interval 19.0 to 36.6
|
15.7 Percentage of participants
Interval 9.2 to 24.2
|
40.0 Percentage of participants
Interval 30.8 to 49.8
|
5.7 Percentage of participants
Interval 2.1 to 12.0
|
17.6 Percentage of participants
Interval 10.8 to 26.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Severe
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Any
|
5.6 Percentage of participants
Interval 2.1 to 11.8
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
10.9 Percentage of participants
Interval 5.8 to 18.3
|
2.9 Percentage of participants
Interval 0.6 to 8.1
|
6.9 Percentage of participants
Interval 2.8 to 13.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Mild
|
3.7 Percentage of participants
Interval 1.0 to 9.3
|
4.9 Percentage of participants
Interval 1.6 to 11.1
|
5.5 Percentage of participants
Interval 2.0 to 11.5
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
4.0 Percentage of participants
Interval 1.1 to 9.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Moderate
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
4.5 Percentage of participants
Interval 1.5 to 10.3
|
1.9 Percentage of participants
Interval 0.2 to 6.7
|
3.0 Percentage of participants
Interval 0.6 to 8.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 deg C and categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=107 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=110 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=105 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=101 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: Any
|
9.3 Percentage of participants
Interval 4.6 to 16.5
|
4.9 Percentage of participants
Interval 1.6 to 11.1
|
11.8 Percentage of participants
Interval 6.4 to 19.4
|
7.6 Percentage of participants
Interval 3.3 to 14.5
|
13.9 Percentage of participants
Interval 7.8 to 22.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >=38.0 deg C to 38.4 deg C
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
7.3 Percentage of participants
Interval 3.2 to 13.8
|
5.7 Percentage of participants
Interval 2.1 to 12.0
|
7.9 Percentage of participants
Interval 3.5 to 15.0
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.4 deg C to 38.9 deg C
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
2.9 Percentage of participants
Interval 0.6 to 8.4
|
2.7 Percentage of participants
Interval 0.6 to 7.8
|
1.9 Percentage of participants
Interval 0.2 to 6.7
|
4.0 Percentage of participants
Interval 1.1 to 9.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.9 deg C to 40.0 deg C
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
0 Percentage of participants
Interval 0.0 to 3.6
|
1.8 Percentage of participants
Interval 0.2 to 6.4
|
0 Percentage of participants
Interval 0.0 to 3.5
|
2.0 Percentage of participants
Interval 0.2 to 7.0
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Any
|
67.3 Percentage of participants
Interval 57.5 to 76.0
|
62.7 Percentage of participants
Interval 52.6 to 72.1
|
69.1 Percentage of participants
Interval 59.6 to 77.6
|
39.0 Percentage of participants
Interval 29.7 to 49.1
|
53.5 Percentage of participants
Interval 43.3 to 63.5
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Mild
|
25.2 Percentage of participants
Interval 17.3 to 34.6
|
30.4 Percentage of participants
Interval 21.7 to 40.3
|
24.5 Percentage of participants
Interval 16.8 to 33.7
|
20.0 Percentage of participants
Interval 12.8 to 28.9
|
23.8 Percentage of participants
Interval 15.9 to 33.3
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Moderate
|
42.1 Percentage of participants
Interval 32.6 to 52.0
|
30.4 Percentage of participants
Interval 21.7 to 40.3
|
43.6 Percentage of participants
Interval 34.2 to 53.4
|
18.1 Percentage of participants
Interval 11.3 to 26.8
|
25.7 Percentage of participants
Interval 17.6 to 35.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
4.0 Percentage of participants
Interval 1.1 to 9.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Any
|
50.5 Percentage of participants
Interval 40.6 to 60.3
|
44.1 Percentage of participants
Interval 34.3 to 54.3
|
45.5 Percentage of participants
Interval 35.9 to 55.2
|
29.5 Percentage of participants
Interval 21.0 to 39.2
|
35.6 Percentage of participants
Interval 26.4 to 45.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Mild
|
26.2 Percentage of participants
Interval 18.1 to 35.6
|
32.4 Percentage of participants
Interval 23.4 to 42.3
|
27.3 Percentage of participants
Interval 19.2 to 36.6
|
21.9 Percentage of participants
Interval 14.4 to 31.0
|
20.8 Percentage of participants
Interval 13.4 to 30.0
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Moderate
|
24.3 Percentage of participants
Interval 16.5 to 33.5
|
11.8 Percentage of participants
Interval 6.2 to 19.6
|
17.3 Percentage of participants
Interval 10.7 to 25.7
|
7.6 Percentage of participants
Interval 3.3 to 14.5
|
13.9 Percentage of participants
Interval 7.8 to 22.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.0 to 5.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Any
|
23.4 Percentage of participants
Interval 15.7 to 32.5
|
14.7 Percentage of participants
Interval 8.5 to 23.1
|
27.3 Percentage of participants
Interval 19.2 to 36.6
|
12.4 Percentage of participants
Interval 6.8 to 20.2
|
22.8 Percentage of participants
Interval 15.0 to 32.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Mild
|
17.8 Percentage of participants
Interval 11.0 to 26.3
|
8.8 Percentage of participants
Interval 4.1 to 16.1
|
17.3 Percentage of participants
Interval 10.7 to 25.7
|
6.7 Percentage of participants
Interval 2.7 to 13.3
|
11.9 Percentage of participants
Interval 6.3 to 19.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Moderate
|
5.6 Percentage of participants
Interval 2.1 to 11.8
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
9.1 Percentage of participants
Interval 4.4 to 16.1
|
5.7 Percentage of participants
Interval 2.1 to 12.0
|
10.9 Percentage of participants
Interval 5.6 to 18.7
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Any
|
2.8 Percentage of participants
Interval 0.6 to 8.0
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
1.8 Percentage of participants
Interval 0.2 to 6.4
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
3.0 Percentage of participants
Interval 0.6 to 8.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Mild
|
2.8 Percentage of participants
Interval 0.6 to 8.0
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
2.0 Percentage of participants
Interval 0.2 to 7.0
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.4
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.0 to 5.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Any
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
13.7 Percentage of participants
Interval 7.7 to 22.0
|
12.7 Percentage of participants
Interval 7.1 to 20.4
|
8.6 Percentage of participants
Interval 4.0 to 15.6
|
6.9 Percentage of participants
Interval 2.8 to 13.8
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Mild
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
9.8 Percentage of participants
Interval 4.8 to 17.3
|
11.8 Percentage of participants
Interval 6.4 to 19.4
|
8.6 Percentage of participants
Interval 4.0 to 15.6
|
5.9 Percentage of participants
Interval 2.2 to 12.5
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.4
|
2.9 Percentage of participants
Interval 0.6 to 8.4
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.0 to 5.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Any
|
26.2 Percentage of participants
Interval 18.1 to 35.6
|
31.4 Percentage of participants
Interval 22.5 to 41.3
|
41.8 Percentage of participants
Interval 32.5 to 51.6
|
20.0 Percentage of participants
Interval 12.8 to 28.9
|
22.8 Percentage of participants
Interval 15.0 to 32.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Mild
|
11.2 Percentage of participants
Interval 5.9 to 18.8
|
17.6 Percentage of participants
Interval 10.8 to 26.4
|
21.8 Percentage of participants
Interval 14.5 to 30.7
|
12.4 Percentage of participants
Interval 6.8 to 20.2
|
12.9 Percentage of participants
Interval 7.0 to 21.0
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Moderate
|
15.0 Percentage of participants
Interval 8.8 to 23.1
|
13.7 Percentage of participants
Interval 7.7 to 22.0
|
19.1 Percentage of participants
Interval 12.2 to 27.7
|
7.6 Percentage of participants
Interval 3.3 to 14.5
|
8.9 Percentage of participants
Interval 4.2 to 16.2
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.0 to 5.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Any
|
12.1 Percentage of participants
Interval 6.6 to 19.9
|
16.7 Percentage of participants
Interval 10.0 to 25.3
|
24.5 Percentage of participants
Interval 16.8 to 33.7
|
11.4 Percentage of participants
Interval 6.0 to 19.1
|
14.9 Percentage of participants
Interval 8.6 to 23.3
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Mild
|
8.4 Percentage of participants
Interval 3.9 to 15.4
|
9.8 Percentage of participants
Interval 4.8 to 17.3
|
11.8 Percentage of participants
Interval 6.4 to 19.4
|
6.7 Percentage of participants
Interval 2.7 to 13.3
|
5.9 Percentage of participants
Interval 2.2 to 12.5
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Moderate
|
3.7 Percentage of participants
Interval 1.0 to 9.3
|
6.9 Percentage of participants
Interval 2.8 to 13.6
|
11.8 Percentage of participants
Interval 6.4 to 19.4
|
4.8 Percentage of participants
Interval 1.6 to 10.8
|
7.9 Percentage of participants
Interval 3.5 to 15.0
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
0 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.0 to 5.4
|
—
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination through 1 month after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=107 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=103 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=110 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=106 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
|
7.5 Percentage of participants
Interval 3.3 to 14.2
|
2.9 Percentage of participants
Interval 0.6 to 8.3
|
8.2 Percentage of participants
Interval 3.8 to 15.0
|
3.8 Percentage of participants
Interval 1.0 to 9.4
|
6.9 Percentage of participants
Interval 2.8 to 13.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=107 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=103 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=110 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=106 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With SAEs From Study Vaccination Through 6 Month After Study Vaccination
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
0 Percentage of participants
Interval 0.0 to 3.5
|
0.9 Percentage of participants
Interval 0.0 to 5.0
|
3.8 Percentage of participants
Interval 1.0 to 9.4
|
0 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable for the specified rows. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=310 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=301 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Any
|
6.5 Percentage of participants
Interval 4.0 to 9.8
|
4.0 Percentage of participants
Interval 2.1 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Mild
|
4.9 Percentage of participants
Interval 2.7 to 7.9
|
2.3 Percentage of participants
Interval 0.9 to 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Moderate
|
1.6 Percentage of participants
Interval 0.5 to 3.7
|
1.7 Percentage of participants
Interval 0.5 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Any
|
7.1 Percentage of participants
Interval 4.5 to 10.6
|
2.7 Percentage of participants
Interval 1.2 to 5.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Mild
|
5.8 Percentage of participants
Interval 3.5 to 9.1
|
1.7 Percentage of participants
Interval 0.5 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Moderate
|
1.3 Percentage of participants
Interval 0.4 to 3.3
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Any
|
76.1 Percentage of participants
Interval 71.0 to 80.8
|
57.1 Percentage of participants
Interval 51.3 to 62.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Mild
|
57.4 Percentage of participants
Interval 51.7 to 63.0
|
48.8 Percentage of participants
Interval 43.1 to 54.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Moderate
|
18.7 Percentage of participants
Interval 14.5 to 23.5
|
8.0 Percentage of participants
Interval 5.2 to 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 deg C and categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=309 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=301 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: Any
|
4.9 Percentage of participants
Interval 2.7 to 7.9
|
4.3 Percentage of participants
Interval 2.3 to 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >=38.0 deg C to 38.4 deg C
|
2.9 Percentage of participants
Interval 1.3 to 5.5
|
3.3 Percentage of participants
Interval 1.6 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.4 deg C to 38.9 deg C
|
1.9 Percentage of participants
Interval 0.7 to 4.2
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Any
|
61.2 Percentage of participants
Interval 55.5 to 66.6
|
38.5 Percentage of participants
Interval 33.0 to 44.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Mild
|
26.9 Percentage of participants
Interval 22.0 to 32.2
|
18.6 Percentage of participants
Interval 14.4 to 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Moderate
|
32.4 Percentage of participants
Interval 27.2 to 37.9
|
18.6 Percentage of participants
Interval 14.4 to 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Severe
|
1.9 Percentage of participants
Interval 0.7 to 4.2
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Any
|
46.6 Percentage of participants
Interval 40.9 to 52.3
|
30.7 Percentage of participants
Interval 25.5 to 36.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Mild
|
28.2 Percentage of participants
Interval 23.2 to 33.5
|
20.7 Percentage of participants
Interval 16.2 to 25.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Moderate
|
17.8 Percentage of participants
Interval 13.7 to 22.5
|
10.0 Percentage of participants
Interval 6.8 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Severe
|
0.6 Percentage of participants
Interval 0.1 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Any
|
22.0 Percentage of participants
Interval 17.5 to 27.0
|
12.0 Percentage of participants
Interval 8.5 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Mild
|
12.3 Percentage of participants
Interval 8.9 to 16.5
|
7.0 Percentage of participants
Interval 4.4 to 10.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Moderate
|
9.1 Percentage of participants
Interval 6.1 to 12.8
|
4.7 Percentage of participants
Interval 2.6 to 7.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Severe
|
0.6 Percentage of participants
Interval 0.1 to 2.3
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Any
|
1.9 Percentage of participants
Interval 0.7 to 4.2
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Mild
|
1.6 Percentage of participants
Interval 0.5 to 3.7
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Moderate
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Any
|
10.7 Percentage of participants
Interval 7.5 to 14.7
|
9.6 Percentage of participants
Interval 6.5 to 13.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Mild
|
8.7 Percentage of participants
Interval 5.8 to 12.5
|
7.6 Percentage of participants
Interval 4.9 to 11.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Moderate
|
1.6 Percentage of participants
Interval 0.5 to 3.7
|
2.0 Percentage of participants
Interval 0.7 to 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Any
|
30.4 Percentage of participants
Interval 25.3 to 35.9
|
18.0 Percentage of participants
Interval 13.8 to 22.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Mild
|
15.2 Percentage of participants
Interval 11.4 to 19.7
|
10.0 Percentage of participants
Interval 6.8 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Moderate
|
15.2 Percentage of participants
Interval 11.4 to 19.7
|
8.0 Percentage of participants
Interval 5.2 to 11.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Any
|
14.9 Percentage of participants
Interval 11.1 to 19.4
|
12.0 Percentage of participants
Interval 8.5 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Mild
|
6.8 Percentage of participants
Interval 4.3 to 10.2
|
6.7 Percentage of participants
Interval 4.1 to 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Moderate
|
8.1 Percentage of participants
Interval 5.3 to 11.7
|
5.3 Percentage of participants
Interval 3.1 to 8.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination through 1 month after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=313 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=306 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
|
6.1 Percentage of participants
Interval 3.7 to 9.3
|
6.9 Percentage of participants
Interval 4.3 to 10.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=313 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=306 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With SAEs From Study Vaccination Through 6 Month After Study Vaccination
|
0.6 Percentage of participants
Interval 0.1 to 2.3
|
3.3 Percentage of participants
Interval 1.6 to 5.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP: all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Model based GMT of OMI BA.4/BA.5 NTs induced by BNT162b2 Bivalent 30mcg groups of study C4591044 Cohort 2/3 combined and BNT162b2 30mcg of study C4591031 \[NCT04955626\] Substudy E among participants \>55 years are reported as descriptive data. GMTs and 95% CIs were calculated by exponentiating least square (LS) means and corresponding CI based on analysis of logarithmically transformed NT using a linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ were set to 0.5\*LLOQ. Model based geometric mean ratio (GMR) are reported in statistical section: OMI BA.4/BA.5 NTs induced 1 month post BNT162b2 Bivalent vaccination in study C4591044 to 1 month post BNT162b2 vaccination in study C4591031 \[NCT04955626\] among participants \>55 years. Outcome measure was planned per protocol to be analyzed in participants of Cohort 2 (Group 4) + Cohort 3 (Group 2) of C4591044 and BNT162b2 experienced participants of study C4591031 \[NCT04955626\] (control arm).
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=282 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=273 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMR of Omicron (BA.4/BA.5)- NT of BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30 mcg in C4591031 [NCT04955626]- 1 Month After Vaccination Among Participants >55 Years
|
3373.4 Titer
Interval 3000.3 to 3793.0
|
1160.7 Titer
Interval 1030.3 to 1307.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP: all eligible, randomized participants who received study intervention to which they were randomized, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Seroresponse: achieving \>=4-fold rise in NTs from baseline (before study vaccination). If baseline measurement was below LLOQ, postvaccination measure of \>= 4\*LLOQ was considered seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 \[NCT05472038\] Cohort 2/3 combined and BNT162b2 30 mcg in Study C4591031 \[NCT04955626\] Substudy E among participants \>55 years of age are presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT162b2 Bivalent \[WT/OMI BA.4/BA.5\] 30 mcg 1 month after vaccination in study C4591044 and 1 month after BNT162b2 vaccination in study C4591031 \[NCT04955626\] among participants \>55 years of age is reported in statistical section. Outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants \>55 years of age from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=282 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=273 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg Cohort2(Group4)/Cohort3(Group2)Combined in C4591044 and BNT162b2 30mcg in C4591031-1 Month After Vaccination in Participants >55 Years
|
66.7 Percentage of participants
Interval 60.8 to 72.1
|
46.5 Percentage of participants
Interval 40.5 to 52.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP: all eligible, randomized participants who received study intervention to which they were randomized, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination and had no other important protocol deviations. Analysis was performed in participants with or without prior evidence of infection up to 1 month post vaccination. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Model based GMT of OMI BA.4/BA.5 NTs induced by BNT162b2 Bivalent 30 mcg groups of study C4591044 \[NCT05472038\] Cohort 2/3 combined in participants 18-55 years of age compared to participants \>55 years of age are presented as descriptive data. GMTs and 2-sided 95% CIs were calculated by exponentiating LS means and corresponding CIs based on analysis of logarithmically transformed NT using a linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ were set to 0.5\*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT162b2 Bivalent vaccination in study C4591044 among participants 18-55 years of age compared to participants \>55 years of age is reported in statistical section. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=294 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=282 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMR of Omicron (BA.4/BA.5)- NTs of BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg Cohort2 (Group2)/Cohort3 (Group1)Combined for 18-55 Years Compared to BNT162b2 30mcg Cohort2 (Group4)/Cohort3 (Group2)Combined for >55 Years- 1 Month After Vaccination in C4591044
|
4254.2 Titer
Interval 3779.6 to 4788.4
|
4344.4 Titer
Interval 3850.2 to 4902.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP: all eligible, randomized participants who received study intervention to which they were randomized, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination and had no important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>= 4\*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 \[NCT05472038\] Cohort 2/3 combined in participants 18-55 years of age compared to participants \>55 years of age are presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT162b2 Bivalent \[WT/OMI BA.4/BA.5\] 30 mcg 1 month after vaccination in study C4591044 in participants 18-55 years of age compared to participants \>55 years of age is reported in statistical section. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=294 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=282 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg Cohort2 (Group2)/Cohort3 (Group1) 18-55 Years and Cohort2 (Group4)/Cohort3 (Group2) >55 Years- 1 Month After Vaccination in C4591044
|
61.2 Percentage of participants
Interval 55.4 to 66.8
|
66.7 Percentage of participants
Interval 60.8 to 72.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline (before study vaccination)Population: EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 Bivalent (WT/OMI BA.1) experienced participants from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=105 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=95 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=98 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
1105.8 Titer
Interval 835.1 to 1464.3
|
338.3 Titer
Interval 238.1 to 480.7
|
607.0 Titer
Interval 433.2 to 850.6
|
301.9 Titer
Interval 215.6 to 422.8
|
582.4 Titer
Interval 397.6 to 853.1
|
151.5 Titer
Interval 113.4 to 202.3
|
420.6 Titer
Interval 312.7 to 565.6
|
225.4 Titer
Interval 164.1 to 309.6
|
249.6 Titer
Interval 180.5 to 345.2
|
|
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Omicron BA.1
|
1190.5 Titer
Interval 921.8 to 1537.5
|
346.0 Titer
Interval 240.0 to 498.9
|
653.1 Titer
Interval 466.3 to 914.8
|
365.1 Titer
Interval 260.8 to 511.1
|
581.2 Titer
Interval 392.5 to 860.6
|
194.6 Titer
Interval 142.4 to 266.0
|
492.4 Titer
Interval 351.5 to 689.9
|
316.3 Titer
Interval 215.9 to 463.4
|
285.6 Titer
Interval 195.8 to 416.5
|
|
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Reference-strain
|
6863.3 Titer
Interval 5587.8 to 8430.1
|
2349.0 Titer
Interval 1693.4 to 3258.4
|
4287.4 Titer
Interval 3245.6 to 5663.8
|
2643.1 Titer
Interval 1990.8 to 3509.1
|
4324.8 Titer
Interval 3099.0 to 6035.4
|
1338.4 Titer
Interval 1056.9 to 1695.1
|
3933.2 Titer
Interval 3058.0 to 5058.9
|
1985.7 Titer
Interval 1510.1 to 2611.0
|
2509.3 Titer
Interval 1906.8 to 3302.3
|
PRIMARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''Number Analyzed'' signifies participants evaluable for specified rows.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=105 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=95 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=99 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
8212.8 Titer
Interval 6807.3 to 9908.7
|
2839.0 Titer
Interval 2150.0 to 3748.8
|
5454.2 Titer
Interval 4292.2 to 6930.8
|
3019.8 Titer
Interval 2327.5 to 3918.0
|
5472.8 Titer
Interval 3930.9 to 7619.6
|
1072.0 Titer
Interval 816.1 to 1408.1
|
2525.2 Titer
Interval 1970.5 to 3236.0
|
943.4 Titer
Interval 733.4 to 1213.6
|
1520.9 Titer
Interval 1196.0 to 1934.0
|
|
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection
Omicron BA.1
|
6687.6 Titer
Interval 5617.0 to 7962.3
|
2407.2 Titer
Interval 1884.9 to 3074.2
|
4112.4 Titer
Interval 3263.6 to 5181.9
|
2656.1 Titer
Interval 2089.6 to 3376.3
|
4264.0 Titer
Interval 3247.9 to 5597.9
|
1819.0 Titer
Interval 1401.6 to 2360.6
|
3143.8 Titer
Interval 2486.9 to 3974.1
|
1617.7 Titer
Interval 1274.7 to 2053.0
|
1936.9 Titer
Interval 1489.4 to 2518.8
|
|
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection
Reference-strain
|
23641.3 Titer
Interval 20473.1 to 27299.8
|
11919.3 Titer
Interval 9839.1 to 14439.3
|
18614.7 Titer
Interval 15754.1 to 21994.7
|
12103.8 Titer
Interval 9992.0 to 14662.0
|
22982.3 Titer
Interval 18524.3 to 28513.3
|
6913.9 Titer
Interval 5690.4 to 8400.5
|
14685.8 Titer
Interval 12301.1 to 17532.8
|
7128.6 Titer
Interval 5954.4 to 8534.3
|
11106.5 Titer
Interval 8956.8 to 13772.2
|
PRIMARY outcome
Timeframe: From before the study vaccination to 1 month after the study vaccinationPopulation: EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
GMFR from before the study vaccination to 1 month after the study vaccination for each strain-specific neutralizing titer was reported in this outcome measure. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=105 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=95 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=98 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
7.6 Fold rise
Interval 6.0 to 9.6
|
8.4 Fold rise
Interval 6.3 to 11.1
|
9.0 Fold rise
Interval 6.9 to 11.8
|
10.0 Fold rise
Interval 7.5 to 13.3
|
9.3 Fold rise
Interval 6.8 to 12.8
|
7.1 Fold rise
Interval 5.7 to 8.9
|
6.0 Fold rise
Interval 4.7 to 7.7
|
4.2 Fold rise
Interval 3.4 to 5.2
|
6.1 Fold rise
Interval 4.7 to 7.9
|
|
Cohort 2: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.1
|
5.6 Fold rise
Interval 4.6 to 6.9
|
7.0 Fold rise
Interval 5.3 to 9.1
|
6.3 Fold rise
Interval 4.9 to 8.2
|
7.3 Fold rise
Interval 5.6 to 9.5
|
7.3 Fold rise
Interval 5.4 to 9.7
|
9.3 Fold rise
Interval 7.3 to 12.0
|
6.4 Fold rise
Interval 4.9 to 8.3
|
5.1 Fold rise
Interval 3.9 to 6.6
|
6.8 Fold rise
Interval 5.1 to 9.1
|
|
Cohort 2: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Reference-strain
|
3.4 Fold rise
Interval 2.9 to 4.1
|
5.1 Fold rise
Interval 3.9 to 6.6
|
4.3 Fold rise
Interval 3.4 to 5.5
|
4.6 Fold rise
Interval 3.7 to 5.8
|
5.4 Fold rise
Interval 4.0 to 7.1
|
5.2 Fold rise
Interval 4.3 to 6.3
|
3.7 Fold rise
Interval 3.0 to 4.6
|
3.6 Fold rise
Interval 2.9 to 4.4
|
4.4 Fold rise
Interval 3.5 to 5.6
|
PRIMARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
Seroresponse was defined as achieving \>= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>= 4\*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 and 60 mcg in Study C4591044 \[NCT05472038\] Cohort 2 and BNT162b2 30 mcg in Study C4591031 \[NCT04955626\] Substudy E are presented as descriptive data. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants 18-55 years of age and \>55 years of age from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=105 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=95 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=102 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=102 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=98 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
n=100 Participants
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
66.3 Percentage of participants
Interval 56.4 to 75.3
|
64.2 Percentage of participants
Interval 53.7 to 73.8
|
66.7 Percentage of participants
Interval 56.6 to 75.7
|
71.3 Percentage of participants
Interval 61.4 to 79.9
|
63.3 Percentage of participants
Interval 52.9 to 72.8
|
62.0 Percentage of participants
Interval 51.7 to 71.5
|
59.0 Percentage of participants
Interval 48.7 to 68.7
|
37.4 Percentage of participants
Interval 27.9 to 47.7
|
53.0 Percentage of participants
Interval 42.8 to 63.1
|
|
Cohort 2: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.1
|
63.8 Percentage of participants
Interval 53.9 to 73.0
|
54.7 Percentage of participants
Interval 44.2 to 65.0
|
60.4 Percentage of participants
Interval 50.2 to 70.0
|
63.7 Percentage of participants
Interval 53.6 to 73.0
|
65.6 Percentage of participants
Interval 55.2 to 75.0
|
75.0 Percentage of participants
Interval 65.3 to 83.1
|
56.7 Percentage of participants
Interval 46.3 to 66.7
|
52.0 Percentage of participants
Interval 41.8 to 62.1
|
58.8 Percentage of participants
Interval 48.3 to 68.7
|
|
Cohort 2: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Reference-strain
|
41.0 Percentage of participants
Interval 31.5 to 51.0
|
49.5 Percentage of participants
Interval 39.1 to 59.9
|
51.5 Percentage of participants
Interval 41.3 to 61.6
|
50.5 Percentage of participants
Interval 40.4 to 60.6
|
55.1 Percentage of participants
Interval 44.7 to 65.2
|
59.6 Percentage of participants
Interval 49.3 to 69.3
|
41.0 Percentage of participants
Interval 31.3 to 51.3
|
41.0 Percentage of participants
Interval 31.3 to 51.3
|
44.4 Percentage of participants
Interval 34.5 to 54.8
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=60 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=60 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=63 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Any
|
4.8 Percentage of participants
Interval 1.0 to 13.5
|
3.3 Percentage of participants
Interval 0.4 to 11.3
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Mild
|
3.2 Percentage of participants
Interval 0.4 to 11.2
|
3.3 Percentage of participants
Interval 0.4 to 11.3
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Moderate
|
1.6 Percentage of participants
Interval 0.0 to 8.7
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Any
|
1.6 Percentage of participants
Interval 0.0 to 8.7
|
3.3 Percentage of participants
Interval 0.4 to 11.3
|
6.7 Percentage of participants
Interval 1.8 to 16.2
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
3.2 Percentage of participants
Interval 0.4 to 11.0
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Mild
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
6.7 Percentage of participants
Interval 1.8 to 16.2
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
3.2 Percentage of participants
Interval 0.4 to 11.0
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Moderate
|
1.6 Percentage of participants
Interval 0.0 to 8.7
|
3.3 Percentage of participants
Interval 0.4 to 11.3
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Any
|
85.5 Percentage of participants
Interval 74.2 to 93.1
|
88.5 Percentage of participants
Interval 77.8 to 95.3
|
76.7 Percentage of participants
Interval 64.0 to 86.6
|
76.7 Percentage of participants
Interval 64.0 to 86.6
|
84.1 Percentage of participants
Interval 72.7 to 92.1
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Mild
|
64.5 Percentage of participants
Interval 51.3 to 76.3
|
65.6 Percentage of participants
Interval 52.3 to 77.3
|
68.3 Percentage of participants
Interval 55.0 to 79.7
|
61.7 Percentage of participants
Interval 48.2 to 73.9
|
68.3 Percentage of participants
Interval 55.3 to 79.4
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Moderate
|
21.0 Percentage of participants
Interval 11.7 to 33.2
|
21.3 Percentage of participants
Interval 11.9 to 33.7
|
8.3 Percentage of participants
Interval 2.8 to 18.4
|
15.0 Percentage of participants
Interval 7.1 to 26.6
|
15.9 Percentage of participants
Interval 7.9 to 27.3
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
1.6 Percentage of participants
Interval 0.0 to 8.8
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 deg C and categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=60 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=60 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=63 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: Any
|
6.5 Percentage of participants
Interval 1.8 to 15.7
|
6.6 Percentage of participants
Interval 1.8 to 15.9
|
10.0 Percentage of participants
Interval 3.8 to 20.5
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
9.5 Percentage of participants
Interval 3.6 to 19.6
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >=38.0 deg C to 38.4 deg C
|
3.2 Percentage of participants
Interval 0.4 to 11.2
|
6.6 Percentage of participants
Interval 1.8 to 15.9
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
4.8 Percentage of participants
Interval 1.0 to 13.3
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.4 deg C to 38.9 deg C
|
3.2 Percentage of participants
Interval 0.4 to 11.2
|
0 Percentage of participants
Interval 0.0 to 5.9
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
0 Percentage of participants
Interval 0.0 to 6.0
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
3.2 Percentage of participants
Interval 0.4 to 11.0
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Any
|
61.3 Percentage of participants
Interval 48.1 to 73.4
|
63.9 Percentage of participants
Interval 50.6 to 75.8
|
73.3 Percentage of participants
Interval 60.3 to 83.9
|
66.7 Percentage of participants
Interval 53.3 to 78.3
|
54.0 Percentage of participants
Interval 40.9 to 66.6
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Mild
|
25.8 Percentage of participants
Interval 15.5 to 38.5
|
29.5 Percentage of participants
Interval 18.5 to 42.6
|
38.3 Percentage of participants
Interval 26.1 to 51.8
|
35.0 Percentage of participants
Interval 23.1 to 48.4
|
17.5 Percentage of participants
Interval 9.1 to 29.1
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Moderate
|
35.5 Percentage of participants
Interval 23.7 to 48.7
|
34.4 Percentage of participants
Interval 22.7 to 47.7
|
33.3 Percentage of participants
Interval 21.7 to 46.7
|
30.0 Percentage of participants
Interval 18.8 to 43.2
|
34.9 Percentage of participants
Interval 23.3 to 48.0
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Any
|
59.7 Percentage of participants
Interval 46.4 to 71.9
|
36.1 Percentage of participants
Interval 24.2 to 49.4
|
41.7 Percentage of participants
Interval 29.1 to 55.1
|
46.7 Percentage of participants
Interval 33.7 to 60.0
|
39.7 Percentage of participants
Interval 27.6 to 52.8
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Mild
|
38.7 Percentage of participants
Interval 26.6 to 51.9
|
16.4 Percentage of participants
Interval 8.2 to 28.1
|
23.3 Percentage of participants
Interval 13.4 to 36.0
|
23.3 Percentage of participants
Interval 13.4 to 36.0
|
22.2 Percentage of participants
Interval 12.7 to 34.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Moderate
|
17.7 Percentage of participants
Interval 9.2 to 29.5
|
19.7 Percentage of participants
Interval 10.6 to 31.8
|
18.3 Percentage of participants
Interval 9.5 to 30.4
|
21.7 Percentage of participants
Interval 12.1 to 34.2
|
17.5 Percentage of participants
Interval 9.1 to 29.1
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Severe
|
3.2 Percentage of participants
Interval 0.4 to 11.2
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Any
|
22.6 Percentage of participants
Interval 12.9 to 35.0
|
18.0 Percentage of participants
Interval 9.4 to 30.0
|
28.3 Percentage of participants
Interval 17.5 to 41.4
|
13.3 Percentage of participants
Interval 5.9 to 24.6
|
19.0 Percentage of participants
Interval 10.2 to 30.9
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Mild
|
11.3 Percentage of participants
Interval 4.7 to 21.9
|
11.5 Percentage of participants
Interval 4.7 to 22.2
|
18.3 Percentage of participants
Interval 9.5 to 30.4
|
8.3 Percentage of participants
Interval 2.8 to 18.4
|
12.7 Percentage of participants
Interval 5.6 to 23.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Moderate
|
11.3 Percentage of participants
Interval 4.7 to 21.9
|
6.6 Percentage of participants
Interval 1.8 to 15.9
|
10.0 Percentage of participants
Interval 3.8 to 20.5
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
6.3 Percentage of participants
Interval 1.8 to 15.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 5.8
|
1.6 Percentage of participants
Interval 0.0 to 8.8
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 5.8
|
1.6 Percentage of participants
Interval 0.0 to 8.8
|
0 Percentage of participants
Interval 0.0 to 6.0
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Any
|
12.9 Percentage of participants
Interval 5.7 to 23.9
|
6.6 Percentage of participants
Interval 1.8 to 15.9
|
16.7 Percentage of participants
Interval 8.3 to 28.5
|
16.7 Percentage of participants
Interval 8.3 to 28.5
|
12.7 Percentage of participants
Interval 5.6 to 23.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Mild
|
9.7 Percentage of participants
Interval 3.6 to 19.9
|
6.6 Percentage of participants
Interval 1.8 to 15.9
|
15.0 Percentage of participants
Interval 7.1 to 26.6
|
13.3 Percentage of participants
Interval 5.9 to 24.6
|
11.1 Percentage of participants
Interval 4.6 to 21.6
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Moderate
|
3.2 Percentage of participants
Interval 0.4 to 11.2
|
0 Percentage of participants
Interval 0.0 to 5.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Any
|
25.8 Percentage of participants
Interval 15.5 to 38.5
|
21.3 Percentage of participants
Interval 11.9 to 33.7
|
45.0 Percentage of participants
Interval 32.1 to 58.4
|
30.0 Percentage of participants
Interval 18.8 to 43.2
|
27.0 Percentage of participants
Interval 16.6 to 39.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Mild
|
19.4 Percentage of participants
Interval 10.4 to 31.4
|
8.2 Percentage of participants
Interval 2.7 to 18.1
|
23.3 Percentage of participants
Interval 13.4 to 36.0
|
11.7 Percentage of participants
Interval 4.8 to 22.6
|
12.7 Percentage of participants
Interval 5.6 to 23.5
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Moderate
|
6.5 Percentage of participants
Interval 1.8 to 15.7
|
11.5 Percentage of participants
Interval 4.7 to 22.2
|
21.7 Percentage of participants
Interval 12.1 to 34.2
|
18.3 Percentage of participants
Interval 9.5 to 30.4
|
14.3 Percentage of participants
Interval 6.7 to 25.4
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
1.6 Percentage of participants
Interval 0.0 to 8.8
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Any
|
14.5 Percentage of participants
Interval 6.9 to 25.8
|
14.8 Percentage of participants
Interval 7.0 to 26.2
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
13.3 Percentage of participants
Interval 5.9 to 24.6
|
17.5 Percentage of participants
Interval 9.1 to 29.1
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Mild
|
9.7 Percentage of participants
Interval 3.6 to 19.9
|
6.6 Percentage of participants
Interval 1.8 to 15.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
3.3 Percentage of participants
Interval 0.4 to 11.5
|
7.9 Percentage of participants
Interval 2.6 to 17.6
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Moderate
|
4.8 Percentage of participants
Interval 1.0 to 13.5
|
8.2 Percentage of participants
Interval 2.7 to 18.1
|
5.0 Percentage of participants
Interval 1.0 to 13.9
|
10.0 Percentage of participants
Interval 3.8 to 20.5
|
9.5 Percentage of participants
Interval 3.6 to 19.6
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 5.9
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination through 1 month after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=60 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=60 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=63 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
|
8.1 Percentage of participants
Interval 2.7 to 17.8
|
9.7 Percentage of participants
Interval 3.6 to 19.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
1.7 Percentage of participants
Interval 0.0 to 8.9
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=62 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=60 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=60 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=63 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination
|
1.6 Percentage of participants
Interval 0.0 to 8.7
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 5.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline (before study vaccination)Population: EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=57 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=56 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=61 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
1332.5 Titer
Interval 909.2 to 1953.0
|
1313.6 Titer
Interval 922.6 to 1870.2
|
1352.0 Titer
Interval 876.0 to 2086.8
|
1320.1 Titer
Interval 869.8 to 2003.6
|
1203.9 Titer
Interval 796.5 to 1819.6
|
—
|
—
|
—
|
—
|
|
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
Reference strain
|
3445.5 Titer
Interval 2465.4 to 4815.3
|
4907.1 Titer
Interval 3753.0 to 6416.1
|
4613.6 Titer
Interval 3474.3 to 6126.4
|
4395.7 Titer
Interval 3244.1 to 5956.3
|
4318.6 Titer
Interval 3196.1 to 5835.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=57 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=56 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=61 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
4850.5 Titer
Interval 3677.1 to 6398.3
|
4854.3 Titer
Interval 3713.9 to 6344.9
|
4944.6 Titer
Interval 3620.3 to 6753.1
|
5180.6 Titer
Interval 3724.6 to 7205.8
|
5455.6 Titer
Interval 4214.2 to 7062.8
|
—
|
—
|
—
|
—
|
|
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Reference strain
|
10455.0 Titer
Interval 8150.7 to 13410.8
|
11360.0 Titer
Interval 9408.3 to 13716.6
|
10840.2 Titer
Interval 8475.3 to 13865.0
|
12303.8 Titer
Interval 9728.6 to 15560.5
|
11164.3 Titer
Interval 8729.0 to 14279.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 1 month after study vaccinationPopulation: EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5\*LLOQ in analysis.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=57 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=56 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=61 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
3.6 Fold rise
Interval 2.7 to 4.8
|
3.7 Fold rise
Interval 2.7 to 5.0
|
3.7 Fold rise
Interval 2.8 to 4.7
|
3.9 Fold rise
Interval 2.9 to 5.3
|
4.5 Fold rise
Interval 3.3 to 6.2
|
—
|
—
|
—
|
—
|
|
Cohort 4: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
Reference strain
|
3.0 Fold rise
Interval 2.3 to 4.0
|
2.3 Fold rise
Interval 1.8 to 3.0
|
2.3 Fold rise
Interval 1.9 to 2.8
|
2.8 Fold rise
Interval 2.1 to 3.7
|
2.6 Fold rise
Interval 2.1 to 3.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
Seroresponse was defined as achieving \>= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>= 4\*LLOQ was considered a seroresponse.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=61 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=57 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
n=56 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=61 Participants
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Omicron BA.4/BA.5
|
42.6 Percentage of participants
Interval 30.0 to 55.9
|
41.0 Percentage of participants
Interval 28.6 to 54.3
|
42.1 Percentage of participants
Interval 29.1 to 55.9
|
39.3 Percentage of participants
Interval 26.5 to 53.2
|
44.3 Percentage of participants
Interval 31.5 to 57.6
|
—
|
—
|
—
|
—
|
|
Cohort 4: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Reference strain
|
37.7 Percentage of participants
Interval 25.6 to 51.0
|
27.9 Percentage of participants
Interval 17.1 to 40.8
|
22.8 Percentage of participants
Interval 12.7 to 35.8
|
26.8 Percentage of participants
Interval 15.8 to 40.3
|
29.5 Percentage of participants
Interval 18.5 to 42.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis in participants with or without prior evidence of infection up to 1 month post vaccination. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Model based GMT of reference strain NTs induced by BNT162b2 Bivalent 30mcg groups of study C4591044 \[NCT05472038\] Cohort 2/3 combined and BNT162b2 30 mcg of study C4591031 \[NCT04955626\] Substudy E among participants \>55 years of age presented as descriptive data. GMTs, 2-sided 95% CIs calculated by exponentiating LS means, corresponding CIs based on analysis of logarithmically transformed NT using linear regression model with terms of baseline NT (log scale), vaccine group. Assay results below LLOQ set to 0.5\*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT162b2 Bivalent vaccination in study C4591044 to 1 month after BNT162b2 vaccination in study C4591031 \[NCT04955626\] among participants \>55 years of age reported in statistical section. Outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants \>55 years of age from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=284 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=287 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMR of the Reference-Strain- NTs of BNT162b2 [WT/OMI BA.4/BA.5] 30mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30mcg in C4591031 [NCT04955626] >55 Years of Age- 1 Month After Vaccination
|
15361.6 Titer
Interval 14082.9 to 16756.5
|
11117.2 Titer
Interval 10196.4 to 12121.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and 1 month after study vaccinationPopulation: EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''Number Analyzed'' signifies participants evaluable for specified rows.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants \>55 years of age from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=297 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=286 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=289 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMT of Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination
Omicron BA.4/BA.5 at baseline
|
569.6 Titer
Interval 471.4 to 688.2
|
458.2 Titer
Interval 365.2 to 574.8
|
205.4 Titer
Interval 170.3 to 247.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMT of Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination
Omicron BA.4/BA.5 at 1 Month
|
4455.9 Titer
Interval 3851.7 to 5154.8
|
4158.1 Titer
Interval 3554.8 to 4863.8
|
938.9 Titer
Interval 802.3 to 1098.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMT of Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination
Reference strain at baseline
|
4017.3 Titer
Interval 3430.7 to 4704.1
|
3690.6 Titer
Interval 3082.2 to 4419.0
|
2699.9 Titer
Interval 2291.7 to 3180.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMT of Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination
Reference strain at 1 Month
|
16323.3 Titer
Interval 14686.5 to 18142.6
|
16250.1 Titer
Interval 14499.2 to 18212.4
|
10415.5 Titer
Interval 9366.7 to 11581.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From before the study vaccination to 1 month after study vaccinationPopulation: EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''Number Analyzed'' signifies participants evaluable for specified rows.
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMFR from before the study vaccination to 1 month after study vaccination for Omicron BA.4/BA.5 and reference strain neutralizing titer was reported in this outcome measure. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants \>55 years of age from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=295 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=284 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=287 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination
Omicron BA.4/BA.5
|
7.8 Fold rise
Interval 6.7 to 9.2
|
8.9 Fold rise
Interval 7.5 to 10.6
|
4.6 Fold rise
Interval 4.0 to 5.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination
Reference strain
|
4.1 Fold rise
Interval 3.6 to 4.6
|
4.4 Fold rise
Interval 3.8 to 5.1
|
3.9 Fold rise
Interval 3.4 to 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after the study vaccinationPopulation: EIP was analyzed. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable for specified rows.
Seroresponse was defined as achieving \>= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>= 4\*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 \[NCT05472038\] Cohort 2/3 combined and BNT162b2 30 mcg in Study C4591031 \[NCT04955626\] Substudy E among participants \>55 years of age are presented as descriptive data. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants \>55 years of age from study C4591031 \[NCT04955626\] Substudy E.
Outcome measures
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
n=295 Participants
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI\] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
n=284 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
n=287 Participants
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
Participants aged \>55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants \>55 years of age in study C4591031 \[NCT04955626\] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 \[NCT05472038\] study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After the Study Vaccination
Omicron BA.4/BA.5
|
61.2 Percentage of participants
Interval 55.4 to 66.8
|
66.7 Percentage of participants
Interval 60.8 to 72.1
|
46.5 Percentage of participants
Interval 40.5 to 52.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After the Study Vaccination
Reference strain
|
44.1 Percentage of participants
Interval 38.3 to 49.9
|
45.8 Percentage of participants
Interval 39.9 to 51.8
|
48.1 Percentage of participants
Interval 42.2 to 54.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
Serious events: 1 serious events
Other events: 97 other events
Deaths: 0 deaths
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
Serious events: 2 serious events
Other events: 91 other events
Deaths: 0 deaths
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Serious events: 1 serious events
Other events: 96 other events
Deaths: 0 deaths
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Serious events: 2 serious events
Other events: 269 other events
Deaths: 0 deaths
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Serious events: 1 serious events
Other events: 106 other events
Deaths: 0 deaths
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Serious events: 10 serious events
Other events: 210 other events
Deaths: 1 deaths
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Cohort 4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/ BA.5] 30 mcg)
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
n=104 participants at risk
Participants aged 18-55 years received BNT162b5 Bivalent (WT/ OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
n=102 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=107 participants at risk
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=313 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
n=110 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=306 participants at risk
Participants aged \> 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
n=102 participants at risk
Participants aged \>55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=62 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=62 participants at risk
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=60 participants at risk
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=60 participants at risk
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/ BA.5] 30 mcg)
n=63 participants at risk
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.96%
1/104 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.93%
1/107 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.98%
1/102 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.32%
1/313 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Gastroenteritis
|
0.96%
1/104 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.32%
1/313 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.96%
1/104 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.98%
1/102 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.98%
1/102 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.93%
1/107 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular germ cell cancer
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.91%
1/110 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
Other adverse events
| Measure |
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
n=104 participants at risk
Participants aged 18-55 years received BNT162b5 Bivalent (WT/ OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
n=102 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=107 participants at risk
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=313 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
n=110 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
n=306 participants at risk
Participants aged \> 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
n=102 participants at risk
Participants aged \>55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=62 participants at risk
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=62 participants at risk
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=60 participants at risk
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
n=60 participants at risk
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
Cohort 4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/ BA.5] 30 mcg)
n=63 participants at risk
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
18.3%
19/104 • Number of events 19 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
17.6%
18/102 • Number of events 18 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
12.1%
13/107 • Number of events 13 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
14.7%
46/313 • Number of events 46 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
24.5%
27/110 • Number of events 27 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
11.8%
36/306 • Number of events 36 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
14.7%
15/102 • Number of events 15 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
14.5%
9/62 • Number of events 9 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
14.5%
9/62 • Number of events 9 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
5.0%
3/60 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
13.3%
8/60 • Number of events 8 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
17.5%
11/63 • Number of events 11 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/63 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Investigations
Blood pressure increased
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/63 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
COVID-19
|
2.9%
3/104 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.9%
4/102 • Number of events 4 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Chills (CHILLS)
|
21.2%
22/104 • Number of events 22 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
19.6%
20/102 • Number of events 20 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
23.4%
25/107 • Number of events 25 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
21.7%
68/313 • Number of events 68 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
27.3%
30/110 • Number of events 30 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
11.8%
36/306 • Number of events 36 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
22.5%
23/102 • Number of events 23 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
22.6%
14/62 • Number of events 14 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
17.7%
11/62 • Number of events 11 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
28.3%
17/60 • Number of events 17 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
13.3%
8/60 • Number of events 8 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
19.0%
12/63 • Number of events 12 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
14.4%
15/104 • Number of events 15 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
19.6%
20/102 • Number of events 20 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.5%
7/107 • Number of events 7 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
10.5%
33/313 • Number of events 33 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
12.7%
14/110 • Number of events 14 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
9.2%
28/306 • Number of events 28 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.9%
7/102 • Number of events 7 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
12.9%
8/62 • Number of events 8 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.5%
4/62 • Number of events 4 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
16.7%
10/60 • Number of events 10 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
16.7%
10/60 • Number of events 10 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
12.7%
8/63 • Number of events 8 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Fatigue
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
2.8%
3/107 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.64%
2/313 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.91%
1/110 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Fatigue (FATIGUE)
|
73.1%
76/104 • Number of events 76 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
62.7%
64/102 • Number of events 64 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
67.3%
72/107 • Number of events 72 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
60.4%
189/313 • Number of events 189 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
69.1%
76/110 • Number of events 76 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
37.6%
115/306 • Number of events 115 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
52.9%
54/102 • Number of events 54 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
61.3%
38/62 • Number of events 38 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
62.9%
39/62 • Number of events 39 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
73.3%
44/60 • Number of events 44 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
65.0%
39/60 • Number of events 39 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
54.0%
34/63 • Number of events 34 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Nervous system disorders
Headache (HEADACHE)
|
52.9%
55/104 • Number of events 55 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
46.1%
47/102 • Number of events 47 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
50.5%
54/107 • Number of events 54 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
46.0%
144/313 • Number of events 144 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
45.5%
50/110 • Number of events 50 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
30.1%
92/306 • Number of events 92 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
35.3%
36/102 • Number of events 36 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
59.7%
37/62 • Number of events 37 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
35.5%
22/62 • Number of events 22 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
41.7%
25/60 • Number of events 25 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
46.7%
28/60 • Number of events 28 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
39.7%
25/63 • Number of events 25 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Injection site erythema (REDNESS)
|
5.8%
6/104 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
5.9%
6/102 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
5.6%
6/107 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.4%
20/313 • Number of events 20 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
10.9%
12/110 • Number of events 12 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.6%
11/306 • Number of events 11 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.9%
7/102 • Number of events 7 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
4.8%
3/62 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.2%
2/62 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
5.0%
3/60 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/63 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Injection site pain
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.9%
2/107 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.64%
2/313 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.98%
1/102 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
4.8%
3/62 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.3%
2/60 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
4.8%
3/63 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Injection site pain (PAIN)
|
82.7%
86/104 • Number of events 86 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
81.4%
83/102 • Number of events 83 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
70.1%
75/107 • Number of events 75 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
75.1%
235/313 • Number of events 235 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
93.6%
103/110 • Number of events 103 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
55.9%
171/306 • Number of events 171 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
69.6%
71/102 • Number of events 71 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
83.9%
52/62 • Number of events 52 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
87.1%
54/62 • Number of events 54 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
75.0%
45/60 • Number of events 45 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
76.7%
46/60 • Number of events 46 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
82.5%
52/63 • Number of events 52 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Injection site swelling (SWELLING)
|
10.6%
11/104 • Number of events 11 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
10.8%
11/102 • Number of events 11 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
7.5%
8/107 • Number of events 8 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
7.0%
22/313 • Number of events 22 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
15.5%
17/110 • Number of events 17 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
2.6%
8/306 • Number of events 8 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
8.8%
9/102 • Number of events 9 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.2%
2/62 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.7%
4/60 • Number of events 4 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.3%
2/60 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.2%
2/63 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.9%
6/313 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.91%
1/110 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.33%
1/306 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.9%
2/107 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
35.6%
37/104 • Number of events 37 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
38.2%
39/102 • Number of events 39 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
26.2%
28/107 • Number of events 28 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
30.0%
94/313 • Number of events 94 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
41.8%
46/110 • Number of events 46 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
17.6%
54/306 • Number of events 54 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
22.5%
23/102 • Number of events 23 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
25.8%
16/62 • Number of events 16 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
21.0%
13/62 • Number of events 13 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
45.0%
27/60 • Number of events 27 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
28.3%
17/60 • Number of events 17 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
27.0%
17/63 • Number of events 17 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Otitis media
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
General disorders
Pyrexia (FEVER)
|
1.9%
2/104 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
5.9%
6/102 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
9.3%
10/107 • Number of events 10 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
4.8%
15/313 • Number of events 15 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
11.8%
13/110 • Number of events 13 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
4.2%
13/306 • Number of events 13 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
13.7%
14/102 • Number of events 14 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.5%
4/62 • Number of events 4 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
6.5%
4/62 • Number of events 4 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
10.0%
6/60 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
5.0%
3/60 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
9.5%
6/63 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.9%
2/107 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.32%
1/313 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.7%
1/60 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
0.96%
1/104 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
2.0%
2/102 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
2.8%
3/107 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.9%
6/313 • Number of events 6 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.8%
2/110 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.65%
2/306 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
2.9%
3/102 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
3.3%
2/60 • Number of events 2 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
5.0%
3/60 • Number of events 3 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/63 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/104 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/107 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/313 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/110 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/306 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/102 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/62 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
1.6%
1/62 • Number of events 1 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/60 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
0.00%
0/63 • Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized \& combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER