Trial Outcomes & Findings for Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People (NCT NCT05541861)
NCT ID: NCT05541861
Last Updated: 2026-01-13
Results Overview
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
383 participants
Primary outcome timeframe
Up to 7 days post-dose1
Results posted on
2026-01-13
Participant Flow
Participant milestones
| Measure |
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 micrograms (mcg) along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
Participants aged greater than (\>) 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \> 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
46
|
45
|
45
|
45
|
46
|
45
|
22
|
59
|
|
Overall Study
Safety Set- Post Dose 1
|
29
|
48
|
44
|
44
|
43
|
46
|
45
|
21
|
59
|
|
Overall Study
Safety Set- Post Dose 2
|
0
|
0
|
30
|
30
|
31
|
37
|
34
|
19
|
0
|
|
Overall Study
Dose 1 (At Day 1)
|
29
|
46
|
44
|
44
|
45
|
46
|
45
|
21
|
59
|
|
Overall Study
Dose 2 (At 6 Months for Cohorts 1, 2, 3a, 3b,4a, 4b and Comparator Cohorts;at 2 Months for Cohort 5)
|
0
|
0
|
30
|
30
|
31
|
37
|
34
|
19
|
0
|
|
Overall Study
COMPLETED
|
29
|
46
|
44
|
44
|
45
|
46
|
45
|
19
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 micrograms (mcg) along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
Participants aged greater than (\>) 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \> 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Randomized but not dosed
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
Baseline characteristics by cohort
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=45 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=45 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=22 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=30 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 10.02 • n=210 Participants
|
40.2 years
STANDARD_DEVIATION 10.67 • n=19 Participants
|
40.6 years
STANDARD_DEVIATION 9.67 • n=123 Participants
|
67.3 years
STANDARD_DEVIATION 5.72 • n=123 Participants
|
40.9 years
STANDARD_DEVIATION 10.57 • n=615 Participants
|
67.1 years
STANDARD_DEVIATION 7.14 • n=20 Participants
|
37.9 years
STANDARD_DEVIATION 11.78 • n=13 Participants
|
38.9 years
STANDARD_DEVIATION 10.84 • n=335 Participants
|
67.5 years
STANDARD_DEVIATION 6.57 • n=451 Participants
|
48.8 years
STANDARD_DEVIATION 15.66 • n=6 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=210 Participants
|
29 Participants
n=19 Participants
|
27 Participants
n=123 Participants
|
25 Participants
n=123 Participants
|
24 Participants
n=615 Participants
|
27 Participants
n=20 Participants
|
11 Participants
n=13 Participants
|
31 Participants
n=335 Participants
|
20 Participants
n=451 Participants
|
224 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=210 Participants
|
16 Participants
n=19 Participants
|
18 Participants
n=123 Participants
|
20 Participants
n=123 Participants
|
22 Participants
n=615 Participants
|
18 Participants
n=20 Participants
|
11 Participants
n=13 Participants
|
28 Participants
n=335 Participants
|
10 Participants
n=451 Participants
|
159 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=210 Participants
|
16 Participants
n=19 Participants
|
18 Participants
n=123 Participants
|
11 Participants
n=123 Participants
|
14 Participants
n=615 Participants
|
11 Participants
n=20 Participants
|
13 Participants
n=13 Participants
|
22 Participants
n=335 Participants
|
6 Participants
n=451 Participants
|
131 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=210 Participants
|
29 Participants
n=19 Participants
|
27 Participants
n=123 Participants
|
34 Participants
n=123 Participants
|
32 Participants
n=615 Participants
|
34 Participants
n=20 Participants
|
9 Participants
n=13 Participants
|
36 Participants
n=335 Participants
|
24 Participants
n=451 Participants
|
251 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=13 Participants
|
3 Participants
n=335 Participants
|
1 Participants
n=451 Participants
|
11 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
4 Participants
n=123 Participants
|
2 Participants
n=123 Participants
|
4 Participants
n=615 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=13 Participants
|
3 Participants
n=335 Participants
|
3 Participants
n=451 Participants
|
25 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=210 Participants
|
37 Participants
n=19 Participants
|
40 Participants
n=123 Participants
|
41 Participants
n=123 Participants
|
39 Participants
n=615 Participants
|
44 Participants
n=20 Participants
|
20 Participants
n=13 Participants
|
50 Participants
n=335 Participants
|
26 Participants
n=451 Participants
|
338 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
3 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
6 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
2 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose1Population: Analysis was performed on safety set that included all participants who received at least one dose of investigational medicinal product (IMP). Here, overall number of participants analyzed signifies participants with available data for the analysis.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=42 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=45 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Reactions- Post Dose 1
Pain
|
30 Participants
|
30 Participants
|
29 Participants
|
30 Participants
|
41 Participants
|
33 Participants
|
13 Participants
|
35 Participants
|
16 Participants
|
|
Number of Participants With Solicited Local Reactions- Post Dose 1
Erythema/Redness
|
7 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local Reactions- Post Dose 1
Induration/Swelling
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 2Population: Analysis was performed on dose 2 safety set, that is, all participants who received two doses of IMP. Here, overall number of participants analyzed signifies participants with available data for the analysis.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B, as these Cohorts did not receive Dose 2 of the study drugs.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Reactions- Post Dose 2
Pain
|
23 Participants
|
18 Participants
|
23 Participants
|
29 Participants
|
24 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions- Post Dose 2
Erythema/Redness
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions- Post Dose 2
Induration/Swelling
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 1Population: Analysis was performed on safety set that included all participants who received at least one dose of IMP. Here, overall number of participants analyzed signifies participants with available data for the analysis.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=42 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Vomiting
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Diarrhea
|
7 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Headache
|
16 Participants
|
13 Participants
|
16 Participants
|
13 Participants
|
21 Participants
|
12 Participants
|
3 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Fatigue
|
24 Participants
|
16 Participants
|
22 Participants
|
21 Participants
|
27 Participants
|
18 Participants
|
5 Participants
|
21 Participants
|
8 Participants
|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Myalgia
|
21 Participants
|
20 Participants
|
20 Participants
|
15 Participants
|
27 Participants
|
13 Participants
|
8 Participants
|
19 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Arthralgia
|
10 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Chills
|
10 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
12 Participants
|
8 Participants
|
0 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Solicited Systemic Events- Post Dose 1
Fever
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 2Population: Analysis was performed on dose 2 safety set. Here, overall number of participants analyzed signifies participants with available data for the analysis. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Diarrhea
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Headache
|
9 Participants
|
10 Participants
|
10 Participants
|
16 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Fatigue
|
12 Participants
|
12 Participants
|
16 Participants
|
19 Participants
|
14 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Myalgia
|
13 Participants
|
14 Participants
|
9 Participants
|
20 Participants
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Arthralgia
|
7 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Chills
|
7 Participants
|
2 Participants
|
5 Participants
|
14 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Systemic Events- Post Dose 2
Fever
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days post-dose 1Population: Analysis was performed on safety set.
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)-Post Dose 1
|
11 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
1 Participants
|
13 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-dose 2Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)-Post Dose 2
|
3 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and up to 2 months post-dose 1 for Cohort 5Population: Analysis was performed on safety set.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 to 7 months post-dose 2 for Cohorts 2 to 4; and up to 3 months post-dose 2 for Cohort 5Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 3 post-Dose 1; at Day 7 post-dose 1Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis.
Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Basophils- Day 3 post dose-1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Basophil-Day 7 post dose-1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Eosinophils- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Eosinophils- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Erythrocytes- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Erythrocytes- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Hematocrit- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Hematocrit- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Hemoglobin- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Hemoglobin- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Leukocytes- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Leukocytes- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Lymphocytes- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Lymphocytes- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Monocytes- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Monocytes- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Neutrophils- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Neutrophils- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Platelets- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Platelets- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7 post-dose 2Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Basophils-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Eosinophils-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Erythrocytes-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Hematocrit-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Hemoglobin-Day 7 post dose-2
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Leukocytes-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Lymphocytes-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Monocytes-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Neutrophils-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Platelets-Day 7 post dose-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 3 post-Dose 1; at Day 7 post-dose 1Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis.
Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only abnormal clinically significant data was reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Aspartate Aminotransferase- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
High Sensitivity C Reactive Protein- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Total Bilirubin- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Alanine Aminotransferase- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Alanine Aminotransferase- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Albumin- Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Albumin- Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Alkaline Phosphatase-Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Alkaline Phosphatase-Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Amylase- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Amylase- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Aspartate Aminotransferase- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
C Reactive Protein- Day 3 post dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
C Reactive Protein- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Creatinine- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Creatinine- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Direct Bilirubin- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Direct Bilirubin- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Gamma Glutamyl Transferase- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Gamma Glutamyl Transferase- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Glucose- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Glucose- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
High Sensitivity C Reactive Protein- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Indirect Bilirubin- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Indirect Bilirubin- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Lipase- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Lipase- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Total Bilirubin- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Troponin I Type 3- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Troponin I Type 3- Day 7 post dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Urea Nitrogen- Day 3 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Urea Nitrogen- Day 7 post dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7 post-dose 2Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only clinically significant abnormal data was reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Alanine Aminotransferase-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Albumin-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Alkaline Phosphatase-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Amylase-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Aspartate Aminotransferase-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
C Reactive Protein-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Creatinine-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Direct Bilirubin-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Gamma Glutamyl Transferase-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Glucose-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
High Sensitivity C Reactive Protein-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Indirect Bilirubin-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Lipase-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Total Bilirubin-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Troponin I Type 3-Day 7 post-dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Urea Nitrogen-Day 7 post-dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 3 post-Dose 1; at Day 7 post-dose 1Population: Analysis was performed on safety set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis.
Participants with only clinically significant new ECG abnormalities were reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=47 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=43 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=43 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=42 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=44 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1
Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1
Day 3 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 7 post-dose 2Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
Participants with only clinically significant new ECG abnormalities were reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 3 post-dose 1; at Day 7 post-dose 1Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis.
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Eosinophils-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Hemoglobin-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7 post-dose 2Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
Eosinophils-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
Hemoglobin-Baseline Grade 0 to Grade >=3
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
Lymphocytes count decreased-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
Neutrophil count decreased-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
Platelet count decreased-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 3 post-dose 1; at Day 7 post-dose 1Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis.
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=48 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 Participants
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Albumin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Amylase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Creatinine: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Glucose: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Lipase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 7 post-dose 2Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=30 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=31 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=34 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=19 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Hypoglycemia-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Hyperglycemia-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Indirect Bilirubin-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Lipase-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Total Bilirubin-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Blood urea nitrogen-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Serum amylase-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Creatinine-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Direct Bilirubin-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Alanine aminotransferase-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Albumin-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Alkaline phosphatase-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
Aspartate aminotransferase-Baseline Grade 0 to Grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Pre-dose and Day 28 post dose-1Population: Analysis was performed on Immunogenicity per protocol set that is all participants who received the planned dose of the IMP on Day 1 and who have at least one valid immunogenicity assessment within an appropriate window and have no major protocol deviations that can confound immunogenicity data. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category.
GMTs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=41 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=42 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=44 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=58 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1
28 days post-dose 1
|
12666.7 titers
Interval 9744.2 to 16465.6
|
13017.3 titers
Interval 9639.5 to 17578.7
|
9571.7 titers
Interval 7120.1 to 12867.4
|
14553.1 titers
Interval 11441.6 to 18510.9
|
10326.7 titers
Interval 7827.3 to 13624.4
|
10126.2 titers
Interval 7730.8 to 13263.9
|
12767.2 titers
Interval 9848.9 to 16550.1
|
14628.7 titers
Interval 10394.8 to 20587.0
|
—
|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1
Pre-dose
|
3310.0 titers
Interval 2404.0 to 4557.4
|
4561.4 titers
Interval 3036.1 to 6853.2
|
3031.5 titers
Interval 1962.7 to 4682.3
|
6245.1 titers
Interval 4446.8 to 8770.5
|
3052.9 titers
Interval 2115.7 to 4405.3
|
2267.0 titers
Interval 1599.6 to 3212.8
|
3579.9 titers
Interval 2447.0 to 5237.3
|
4034.9 titers
Interval 2321.9 to 7011.7
|
—
|
SECONDARY outcome
Timeframe: At Pre-dose 2 and Day 28 post-dose 2Population: Analysis was performed on Immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for the analysis at the specified time-point.
GMTs for SARS-CoV-2 neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=38 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=33 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=36 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=30 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=55 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=27 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2
28 days post-dose 2
|
—
|
10032.4 titers
Interval 6551.6 to 15362.6
|
7329.5 titers
Interval 4942.9 to 10868.6
|
12884.0 titers
Interval 9244.3 to 17956.7
|
7782.0 titers
Interval 4992.9 to 12129.2
|
6294.6 titers
Interval 3683.9 to 10755.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2
Pre-Dose-2
|
5940.9 titers
Interval 4413.3 to 7997.2
|
5717.3 titers
Interval 3725.5 to 8774.0
|
3559.2 titers
Interval 2495.8 to 5075.6
|
5751.4 titers
Interval 4322.6 to 7652.5
|
3862.0 titers
Interval 2713.4 to 5496.7
|
3551.6 titers
Interval 2392.2 to 5272.9
|
5238.7 titers
Interval 3869.6 to 7092.2
|
5490.6 titers
Interval 3394.2 to 8881.9
|
—
|
SECONDARY outcome
Timeframe: At Pre-dose and Day 28 post-dose 1Population: Analysis was performed on immunogenicity per protocol set. Here, number analyzed signifies participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=41 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=42 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=44 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=58 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1
Pre-dose
|
881.7 titers
Interval 553.4 to 1404.5
|
1475.9 titers
Interval 893.5 to 2438.1
|
1125.3 titers
Interval 692.1 to 1829.5
|
1948.8 titers
Interval 1250.3 to 3037.6
|
1067.2 titers
Interval 739.1 to 1541.1
|
625.2 titers
Interval 406.8 to 961.0
|
1485.1 titers
Interval 993.4 to 2220.1
|
1213.0 titers
Interval 665.0 to 2212.8
|
—
|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1
28 days post-dose 1
|
5540.9 titers
Interval 3878.4 to 7916.1
|
6801.2 titers
Interval 5000.7 to 9249.9
|
4690.6 titers
Interval 3313.1 to 6640.9
|
6303.1 titers
Interval 4775.2 to 8319.8
|
5913.9 titers
Interval 4330.8 to 8075.8
|
3907.0 titers
Interval 2802.3 to 5447.3
|
6323.4 titers
Interval 4390.6 to 9107.0
|
6552.0 titers
Interval 3927.7 to 10929.8
|
—
|
SECONDARY outcome
Timeframe: At Pre-dose 2 and Day 28 post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for the analysis at the specified time-point.
GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=38 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=33 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=37 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=36 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=30 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=55 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=27 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2
Pre-dose-2
|
2597.0 titers
Interval 1733.5 to 3890.5
|
2502.1 titers
Interval 1563.8 to 4003.6
|
1750.6 titers
Interval 1223.9 to 2504.1
|
2089.7 titers
Interval 1422.2 to 3070.4
|
2179.6 titers
Interval 1583.2 to 3000.7
|
1663.4 titers
Interval 1057.0 to 2617.8
|
2649.8 titers
Interval 1906.0 to 3683.8
|
2610.0 titers
Interval 1427.1 to 4773.3
|
—
|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2
28 days post-dose 2
|
—
|
6506.3 titers
Interval 4270.1 to 9913.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Pre-dose 2 and Day 28 post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B.
GMTs for SARS-CoV-2 Omicron XBB1.5 strain were measured by valid assay method.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=37 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=37 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=31 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2
Pre-dose-2
|
353.3 titers
Interval 227.1 to 549.6
|
356.8 titers
Interval 219.8 to 579.0
|
608.2 titers
Interval 413.8 to 894.0
|
335.2 titers
Interval 199.1 to 564.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2
28 days post-dose 2
|
2493.1 titers
Interval 1572.4 to 3953.0
|
3325.2 titers
Interval 2110.1 to 5239.8
|
3042.7 titers
Interval 1850.6 to 5002.5
|
1935.9 titers
Interval 1061.7 to 3530.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose 1 to 28 days post-dose 1Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 5.
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=40 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=42 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=40 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=41 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=56 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1
|
3.4 ratio
Interval 2.7 to 4.4
|
2.9 ratio
Interval 2.1 to 4.0
|
3.3 ratio
Interval 2.4 to 4.6
|
2.3 ratio
Interval 1.8 to 3.1
|
3.4 ratio
Interval 2.6 to 4.5
|
4.2 ratio
Interval 3.2 to 5.5
|
3.7 ratio
Interval 2.8 to 4.9
|
3.6 ratio
Interval 2.3 to 5.7
|
—
|
SECONDARY outcome
Timeframe: From pre-dose 2 to 28 days post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis.
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 5 and Comparator Cohorts A and B.
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=25 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=25 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=28 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=26 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=22 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2
|
2.2 ratio
Interval 1.4 to 3.6
|
2.0 ratio
Interval 1.2 to 3.5
|
2.1 ratio
Interval 1.4 to 3.0
|
2.6 ratio
Interval 1.8 to 3.6
|
2.8 ratio
Interval 1.7 to 4.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose 1 to 28 days post-dose 1Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=40 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=42 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=40 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=41 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=56 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1
|
5.4 ratio
Interval 3.6 to 8.1
|
4.5 ratio
Interval 3.0 to 6.8
|
4.4 ratio
Interval 3.0 to 6.5
|
3.1 ratio
Interval 2.2 to 4.4
|
5.8 ratio
Interval 4.3 to 7.8
|
5.9 ratio
Interval 4.2 to 8.2
|
4.3 ratio
Interval 3.2 to 5.7
|
5.4 ratio
Interval 3.4 to 8.7
|
—
|
SECONDARY outcome
Timeframe: From pre-dose 2 to 28 days post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 3a and 3b, 4a and 4b, 5 and Comparator Cohorts A and B.
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=25 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 2
|
4.4 ratio
Interval 2.4 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Pre-dose 2 to Day 28 post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B.
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=25 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=27 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=26 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=22 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2
|
5.6 ratio
Interval 3.7 to 8.5
|
7.8 ratio
Interval 5.5 to 11.1
|
4.9 ratio
Interval 3.2 to 7.4
|
6.5 ratio
Interval 4.2 to 10.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28 post-dose 1Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=40 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=42 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=40 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=41 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=56 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1
|
32.5 percentage of participants
Interval 18.6 to 49.1
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
35.7 percentage of participants
Interval 21.6 to 52.0
|
20.0 percentage of participants
Interval 9.1 to 35.6
|
38.5 percentage of participants
Interval 23.4 to 55.4
|
43.9 percentage of participants
Interval 28.5 to 60.3
|
50.0 percentage of participants
Interval 36.3 to 63.7
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
—
|
SECONDARY outcome
Timeframe: At Day 28 post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts, 1, 5 and Comparator Cohorts A and B.
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=25 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=25 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=28 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=26 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=22 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
23.1 percentage of participants
Interval 9.0 to 43.6
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28 post-dose 1Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=40 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=42 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=40 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=39 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=41 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=56 Participants
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=29 Participants
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1
|
52.5 percentage of participants
Interval 36.1 to 68.5
|
46.2 percentage of participants
Interval 30.1 to 62.8
|
47.6 percentage of participants
Interval 32.0 to 63.6
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
59.0 percentage of participants
Interval 42.1 to 74.4
|
61.0 percentage of participants
Interval 44.5 to 75.8
|
44.6 percentage of participants
Interval 31.3 to 58.5
|
55.2 percentage of participants
Interval 35.7 to 73.6
|
—
|
SECONDARY outcome
Timeframe: At Day 28 post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 3a and 3b, 4a and 4b, 5 and Comparator Cohorts A and B.
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=25 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 2
|
44.0 percentage of participants
Interval 24.4 to 65.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28 post-dose 2Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B.
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Outcome measures
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years)
n=44 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=42 Participants
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=46 Participants
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=44 Participants
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2
|
64.0 percentage of participants
Interval 42.5 to 82.0
|
77.8 percentage of participants
Interval 57.7 to 91.4
|
50.0 percentage of participants
Interval 29.9 to 70.1
|
72.7 percentage of participants
Interval 49.8 to 89.3
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years
n=48 participants at risk
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 participants at risk
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 participants at risk
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 participants at risk
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 participants at risk
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 participants at risk
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 participants at risk
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 participants at risk
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 participants at risk
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.3%
1/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.2%
1/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.3%
1/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.2%
1/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.3%
1/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
|
Nervous system disorders
Spinal cord herniation
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
1.7%
1/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.3%
1/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.3%
1/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
Other adverse events
| Measure |
Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years
n=48 participants at risk
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1.
|
Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years)
n=44 participants at risk
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years)
n=44 participants at risk
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years)
n=46 participants at risk
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years)
n=59 participants at risk
Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years)
n=21 participants at risk
Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively.
|
Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years)
n=43 participants at risk
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years)
n=45 participants at risk
Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years)
n=29 participants at risk
Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.3%
1/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.3%
1/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
10.9%
5/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
9.3%
4/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
22.2%
10/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
3.4%
1/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
|
Nervous system disorders
Headache
|
6.2%
3/48 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/44 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
2.2%
1/46 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
1.7%
1/59 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/21 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/43 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/45 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
0.00%
0/29 • AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER