Trial Outcomes & Findings for A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects (NCT NCT04949490)
NCT ID: NCT04949490
Last Updated: 2024-09-19
Results Overview
For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval "Dose 1 up to 28 days after Dose 1". For other SAEs and AESIs, the data refers to the interval "Dose 1 up to 26 weeks after Dose 1". A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
Up to 26 weeks after the first IMP injection
Results posted on
2024-09-19
Participant Flow
This rollover study (BNT162-14) has enrolled BNT162-01 (NCT04380701) or BNT162-04 (NCT04537949) study participants meeting all inclusion/exclusion criteria defined in the study protocol. The first participant was enrolled on 26 JUL 2021. The last visit of the last participant was on 16 SEP 2022.
All enrolled participants were allocated to treatment. Participants of the Group B immunology subset are also included in the respective Group B arms. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
Participant milestones
| Measure |
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|
|
Group A and Group B
STARTED
|
21
|
44
|
61
|
11
|
0
|
0
|
|
Group A and Group B
COMPLETED
|
21
|
44
|
60
|
9
|
0
|
0
|
|
Group A and Group B
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Subset Group B Immunogenicity Evaluation
STARTED
|
0
|
0
|
0
|
0
|
22
|
11
|
|
Subset Group B Immunogenicity Evaluation
COMPLETED
|
0
|
0
|
0
|
0
|
21
|
9
|
|
Subset Group B Immunogenicity Evaluation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|
|
Group A and Group B
Non-study SARS-COV-2 vaccination
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Group A and Group B
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Subset Group B Immunogenicity Evaluation
Non-study SARS-COV-2 vaccination
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Subset Group B Immunogenicity Evaluation
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
Baseline characteristics by cohort
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group B Non-transplant Participants
n=61 Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=11 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=21 Participants
|
28 Participants
n=44 Participants
|
50 Participants
n=61 Participants
|
11 Participants
n=11 Participants
|
106 Participants
n=137 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=21 Participants
|
16 Participants
n=44 Participants
|
11 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
31 Participants
n=137 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=137 Participants
|
|
Age, Continuous
Group A
|
53.91 years
STANDARD_DEVIATION 15.13 • n=21 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
55.81 years
STANDARD_DEVIATION 15.20 • n=44 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
—
|
—
|
55.19 years
STANDARD_DEVIATION 15.09 • n=65 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
|
Age, Continuous
Group B
|
—
|
—
|
49.17 years
STANDARD_DEVIATION 16.72 • n=61 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
50.88 years
STANDARD_DEVIATION 11.92 • n=11 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
49.43 years
STANDARD_DEVIATION 16.02 • n=72 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
|
Sex: Female, Male
Female
|
9 Participants
n=21 Participants
|
20 Participants
n=44 Participants
|
29 Participants
n=61 Participants
|
5 Participants
n=11 Participants
|
63 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=21 Participants
|
24 Participants
n=44 Participants
|
32 Participants
n=61 Participants
|
6 Participants
n=11 Participants
|
74 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=21 Participants
|
44 Participants
n=44 Participants
|
61 Participants
n=61 Participants
|
11 Participants
n=11 Participants
|
136 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=21 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=21 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=21 Participants
|
42 Participants
n=44 Participants
|
61 Participants
n=61 Participants
|
11 Participants
n=11 Participants
|
135 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=137 Participants
|
|
Region of Enrollment
Germany
|
21 Participants
n=21 Participants
|
44 Participants
n=44 Participants
|
61 Participants
n=61 Participants
|
11 Participants
n=11 Participants
|
137 Participants
n=137 Participants
|
|
Weight
Group A
|
76.76 kg
STANDARD_DEVIATION 10.80 • n=21 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
76.73 kg
STANDARD_DEVIATION 13.45 • n=44 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
—
|
—
|
76.74 kg
STANDARD_DEVIATION 12.57 • n=65 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
|
Weight
Group B
|
—
|
—
|
76.79 kg
STANDARD_DEVIATION 13.86 • n=61 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
74.14 kg
STANDARD_DEVIATION 10.93 • n=11 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
76.38 kg
STANDARD_DEVIATION 13.42 • n=72 Participants • Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
|
PRIMARY outcome
Timeframe: Up to 26 weeks after the first IMP injectionPopulation: Safety set, i.e., all participants who received at least one dose of IMP.
For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval "Dose 1 up to 28 days after Dose 1". For other SAEs and AESIs, the data refers to the interval "Dose 1 up to 26 weeks after Dose 1". A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
Outcome measures
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 Participants
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=61 Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=11 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
n=72 Participants
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
n=22 Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
n=11 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
n=33 Participants
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
Any related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
Any TESAE
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
Any related TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
Any AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
Any related AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
Any TEAESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
Any SAE
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.Population: Safety set, i.e., all participants who received at least one dose of IMP.
Local reactions (pain, tenderness, erythema/redness, induration/swelling) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Outcome measures
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 Participants
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=22 Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=11 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
n=33 Participants
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction
|
20 Participants
|
41 Participants
|
61 Participants
|
21 Participants
|
10 Participants
|
31 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 2 up to 7 days after Dose 2: Number of participants with any local reaction
|
—
|
—
|
—
|
20 Participants
|
5 Participants
|
25 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 local reaction
|
—
|
—
|
—
|
4 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.Population: Safety set, i.e., all participants who received at least one dose of IMP.
Systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Outcome measures
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 Participants
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=22 Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=11 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
n=33 Participants
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction
|
18 Participants
|
33 Participants
|
51 Participants
|
20 Participants
|
8 Participants
|
28 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction
|
4 Participants
|
9 Participants
|
13 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 2 up to 7 days after Dose 2: Number of participants with any systemic reaction
|
—
|
—
|
—
|
17 Participants
|
4 Participants
|
21 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 systemic reaction
|
—
|
—
|
—
|
7 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group A: Up to 28 days after Dose 1. Group B: Up to 28 days after Dose 1 and up to 28 days after Dose 2.Population: Safety set, i.e., all participants who received at least one dose of IMP.
A TEAE is defined as any AE with an onset after the first IMP injection or worsened after the first IMP injection (if the AE was present before the first administration of IMP). AEs with an onset date more than 28 days after the last administration of IMP will be considered as treatment-emergent only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Outcome measures
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 Participants
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=22 Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=11 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
n=33 Participants
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants
Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE
|
8 Participants
|
14 Participants
|
22 Participants
|
5 Participants
|
6 Participants
|
11 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants
Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants
Dose 2 up to 28 days after Dose 2; Number of participants with any TEAE
|
—
|
—
|
—
|
5 Participants
|
2 Participants
|
7 Participants
|
—
|
—
|
—
|
|
The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants
Dose 2 up to 28 days after Dose 2; Number of participants with any grade >=3 TEAE
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
For Group A participants and Group B participants (except transplant subjects). Non-transplant participants of the Group B immunology subset are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
Outcome measures
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 Participants
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=61 Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=22 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers reference strain - Baseline (Day 1)
|
21.4 Titer
Interval 13.2 to 34.5
|
21.3 Titer
Interval 15.3 to 29.6
|
21.3 Titer
Interval 16.4 to 27.7
|
15.6 Titer
Interval 11.5 to 21.0
|
13.3 Titer
Interval 8.3 to 21.3
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers variant B.1.351 - Baseline (Day1)
|
NA Titer
Titers were below lower limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers were below lower limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers were below lower limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers reference strain - Day 8
|
640.0 Titer
Interval 376.6 to 1087.7
|
349.0 Titer
Interval 254.5 to 478.6
|
424.5 Titer
Interval 322.5 to 558.8
|
729.3 Titer
Interval 485.4 to 1095.8
|
1093.4 Titer
Interval 719.8 to 1661.0
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers variant B.1.351 - Day 8
|
285.1 Titer
Interval 164.2 to 495.0
|
330.2 Titer
Interval 232.3 to 469.5
|
314.9 Titer
Interval 235.8 to 420.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers reference strain - Week 3 (Day 22)
|
—
|
—
|
—
|
1085.6 Titer
Interval 775.5 to 1519.5
|
1183.0 Titer
Interval 738.2 to 1896.0
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers reference strain - Week 4 (Day 29)
|
570.2 Titer
Interval 309.3 to 1051.1
|
509.3 Titer
Interval 372.4 to 696.6
|
528.2 Titer
Interval 399.1 to 699.2
|
1789.7 Titer
Interval 1367.3 to 2342.6
|
1868.1 Titer
Interval 1278.7 to 2729.3
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers variant B.1.351 - Week 4 (Day 29)
|
271.3 Titer
Interval 157.9 to 466.1
|
325.1 Titer
Interval 233.2 to 453.3
|
306.6 Titer
Interval 232.4 to 404.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers reference strain - Week 7
|
—
|
—
|
—
|
1386.0 Titer
Interval 1054.5 to 1821.6
|
1429.2 Titer
Interval 864.5 to 2362.8
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers reference strain - Week 12 (Day 85)
|
371.2 Titer
Interval 202.5 to 680.5
|
282.1 Titer
Interval 181.0 to 439.8
|
313.9 Titer
Interval 221.5 to 444.9
|
1348.3 Titer
Interval 992.8 to 1831.1
|
1301.3 Titer
Interval 795.2 to 2129.5
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers variant B.1.351 - Week 12 (Day 85)
|
122.9 Titer
Interval 65.3 to 231.4
|
259.4 Titer
Interval 162.6 to 413.7
|
194.0 Titer
Interval 133.0 to 282.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers reference strain - Week 26 (Day 182)
|
336.2 Titer
Interval 159.6 to 708.6
|
132.0 Titer
Interval 64.6 to 269.7
|
218.4 Titer
Interval 130.0 to 366.8
|
659.8 Titer
Interval 469.5 to 927.1
|
710.1 Titer
Interval 439.5 to 1147.3
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
Response neutralizing antibody titers variant B.1.351 - Week 26 (Day 182)
|
140.2 Titer
Interval 60.4 to 325.2
|
129.5 Titer
Interval 63.8 to 262.6
|
135.1 Titer
Interval 79.3 to 230.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
For Group A participants and Group B participants (except transplant subjects). Non-transplant participants in the Group B immunology subset arm are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
Outcome measures
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 Participants
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=61 Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=22 Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Day 8
|
520744.5 Titer
Interval 258322.6 to 1049752.6
|
480042.7 Titer
Interval 319790.9 to 720599.2
|
492832.1 Titer
Interval 348924.0 to 696092.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day1)
|
2216.1 Titer
Interval 1507.6 to 3257.7
|
2161.4 Titer
Interval 1634.7 to 2857.8
|
2178.9 Titer
Interval 1748.0 to 2716.1
|
2135.4 Titer
Interval 1303.7 to 3497.5
|
2056.4 Titer
Interval 1297.3 to 3259.6
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Baseline (Day 1)
|
566.5 Titer
Interval 370.9 to 865.3
|
588.7 Titer
Interval 438.4 to 790.6
|
581.5 Titer
Interval 459.5 to 735.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1)
|
3209.0 Titer
Interval 2045.6 to 5033.9
|
2594.7 Titer
Interval 1977.5 to 3404.4
|
2779.1 Titer
Interval 2210.9 to 3493.2
|
1634.4 Titer
Interval 1025.5 to 2605.0
|
1636.2 Titer
Interval 885.2 to 3024.5
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Baseline (Day 1)
|
7164.8 Titer
Interval 4231.7 to 12130.9
|
9267.9 Titer
Interval 6837.3 to 12562.5
|
8528.4 Titer
Interval 6572.5 to 11066.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
48945.7 Titer
Interval 35518.9 to 67447.9
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
48805.7 Titer
Interval 29759.0 to 80043.1
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Day 8
|
22903.0 Titer
Interval 11936.4 to 43945.2
|
21244.0 Titer
Interval 15712.2 to 28723.3
|
21766.4 Titer
Interval 16403.7 to 28882.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein reference strain (ELISA) - Day 8
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
45270.4 Titer
Interval 27269.8 to 75153.2
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 3
|
—
|
—
|
—
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein reference strain (ELISA) - Week 3
|
—
|
—
|
—
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 4
|
18959.7 Titer
Interval 11062.8 to 32493.5
|
21082.1 Titer
Interval 16052.9 to 27686.8
|
20371.6 Titer
Interval 15940.0 to 26035.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein reference strain (ELISA) - Week 4
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 4
|
394493.5 Titer
Interval 198914.7 to 782371.2
|
362296.9 Titer
Interval 259569.0 to 505680.9
|
372400.7 Titer
Interval 274455.6 to 505299.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 7
|
—
|
—
|
—
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein reference strain (ELISA) - Week 7
|
—
|
—
|
—
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12
|
23883.9 Titer
Interval 15193.4 to 37545.2
|
28535.3 Titer
Interval 20676.5 to 39381.0
|
26627.5 Titer
Interval 20616.5 to 34391.0
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 12
|
11106.8 Titer
Interval 6446.7 to 19135.5
|
14367.3 Titer
Interval 9798.4 to 21066.5
|
12998.8 Titer
Interval 9570.3 to 17655.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein reference strain (ELISA) - Week 12
|
50709.2 Titer
Interval 33710.6 to 76279.3
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 12
|
178167.5 Titer
Interval 95710.4 to 331663.8
|
305041.0 Titer
Interval 196223.1 to 474205.2
|
247480.6 Titer
Interval 173229.4 to 353558.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26
|
14309.8 Titer
Interval 7900.1 to 25920.0
|
8670.5 Titer
Interval 5238.9 to 14349.9
|
11355.5 Titer
Interval 7717.3 to 16709.0
|
34032.7 Titer
Interval 25327.8 to 45729.3
|
38865.2 Titer
Interval 23611.8 to 63972.6
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 26
|
9829.9 Titer
Interval 4948.4 to 19526.7
|
6967.7 Titer
Interval 4124.5 to 11770.9
|
8386.3 Titer
Interval 5479.1 to 12835.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein reference strain (ELISA) - Week 26
|
27732.0 Titer
Interval 15894.6 to 48385.3
|
17049.8 Titer
Interval 10185.6 to 28539.8
|
22155.2 Titer
Interval 15250.2 to 32186.6
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
NA Titer
Titers above upper limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 26
|
142683.7 Titer
Interval 67849.2 to 300057.1
|
91825.4 Titer
Interval 50843.9 to 165838.9
|
116420.8 Titer
Interval 72901.4 to 185919.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 26 weeks after the first IMP injection (Dose 1)Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
For Group A only. The geometric mean titer (GMT) ratio is calculated as the GMT of reference divided by the GMT of variant B.1.351. The 'Total' arm for Group A include all participants from the two Group A arms/groups.
Outcome measures
| Measure |
Group A Comirnaty
n=21 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 Participants
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Day 1 - Response neutralizing antibody titers - GMT ratio
|
3.1 GMT ratio
|
3.0 GMT ratio
|
3.0 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Day 1 - Response antibody titers IgG RBD Domain - GMT ratio
|
3.9 GMT ratio
|
3.7 GMT ratio
|
3.7 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Day 1 - Response antibody titers IgG S Protein - GMT ratio
|
0.4 GMT ratio
|
0.3 GMT ratio
|
0.3 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Day 8 - Response neutralizing antibody titers - GMT ratio
|
2.2 GMT ratio
|
1.1 GMT ratio
|
1.3 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Day 8 - Response antibody titers IgG RBD Domain - GMT ratio
|
2.9 GMT ratio
|
2.3 GMT ratio
|
2.5 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Day 8 - Response antibody titers IgG S Protein - GMT ratio
|
0.2 GMT ratio
|
0.2 GMT ratio
|
0.2 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 4 (Day 29) - Response neutralizing antibody titers - GMT ratio
|
2.1 GMT ratio
|
1.6 GMT ratio
|
1.7 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 4 (Day 29) - Response antibody titers IgG RBD Domain - GMT ratio
|
3.1 GMT ratio
|
2.6 GMT ratio
|
2.8 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 4 (Day 29) - Response antibody titers IgG S Protein - GMT ratio
|
0.2 GMT ratio
|
0.2 GMT ratio
|
0.2 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 12 (Day 85) - Response neutralizing antibody titers - GMT ratio
|
3.0 GMT ratio
|
1.1 GMT ratio
|
1.6 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 12 (Day 85) - Response antibody titers IgG RBD Domain - GMT ratio
|
2.2 GMT ratio
|
2.0 GMT ratio
|
2.0 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 12 (Day 85) - Response antibody titers IgG S Protein - GMT ratio
|
0.3 GMT ratio
|
0.2 GMT ratio
|
0.2 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 26 (Day 182) - Response neutralizing antibody titers - GMT ratio
|
2.4 GMT ratio
|
1.0 GMT ratio
|
1.6 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 26 (Day 182) - Response antibody titers IgG RBD Domain - GMT ratio
|
1.5 GMT ratio
|
1.2 GMT ratio
|
1.4 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
Week 26 (Day 182) - Response antibody titers IgG S Protein - GMT ratio
|
0.2 GMT ratio
|
0.2 GMT ratio
|
0.2 GMT ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2. Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
Outcome measures
| Measure |
Group A Comirnaty
n=11 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Day 1 of Dose 1
|
NA Titer
Titers were below lower limit of detection. Confidence intervals were not computable.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Day 8 of Dose 1
|
48.3 Titer
Interval 13.0 to 179.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Week 4 (Day 29) of Dose 1
|
124.4 Titer
Interval 25.4 to 609.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Week 12 (Day 85) of Dose 1
|
80.0 Titer
Interval 17.1 to 374.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Week 26 (Day 182) of Dose 1
|
108.9 Titer
Interval 23.1 to 513.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Day 1 pre Dose 2
|
47.6 Titer
Interval 7.3 to 311.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Day 8 post Dose 2
|
142.5 Titer
Interval 9.4 to 2160.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Week 4 (Day 29) post Dose 2
|
452.5 Titer
Interval 61.7 to 3317.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Week 12 (Day 85) post Dose 2
|
142.5 Titer
Interval 21.5 to 945.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
Week 26 (Day 182) post Dose 2
|
127.0 Titer
Interval 19.7 to 819.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2. Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
Outcome measures
| Measure |
Group A Comirnaty
n=11 Participants
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day 1 of Dose 1)
|
730.5 Titer
Interval 157.1 to 3397.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1 of Dose 1)
|
599.1 Titer
Interval 117.1 to 3064.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8 of Dose 1
|
4328.8 Titer
Interval 512.9 to 36532.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Day 8 of Dose 1
|
5078.0 Titer
Interval 528.0 to 48838.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4 (Day 29) of Dose 1
|
6616.9 Titer
Interval 987.7 to 44327.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Week 4 (Day 29) of Dose 1
|
7937.6 Titer
Interval 1179.2 to 53431.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA)- Week 12 (Day 85) of Dose 1
|
5065.9 Titer
Interval 791.0 to 32443.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Week 12 (Day 85) of Dose 1
|
11988.6 Titer
Interval 1607.4 to 89413.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26 (Day 182) of Dose 1
|
10602.6 Titer
Interval 2076.7 to 54130.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Week 26 (Day 182) of Dose 1
|
19644.7 Titer
Interval 5085.2 to 75890.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 1 pre Dose 2
|
3633.0 Titer
Interval 506.1 to 26078.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Day 1 pre Dose 2
|
5822.9 Titer
Interval 894.5 to 37904.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8 post Dose 2
|
12441.7 Titer
Interval 1398.3 to 110702.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Day 8 post Dose 2
|
22067.6 Titer
Interval 2752.2 to 176945.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4 (Day 29) post Dose 2
|
13625.0 Titer
Interval 2884.8 to 64350.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Week 4 (Day 29) post Dose 2
|
34242.9 Titer
Interval 7476.0 to 156845.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12 (Day 85) post Dose 2
|
12265.4 Titer
Interval 1706.1 to 88179.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Week 12 (Day 85) post Dose 2
|
24015.7 Titer
Interval 3852.9 to 149692.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26 (Day 182) post Dose 2
|
13468.1 Titer
Interval 2320.5 to 78167.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
Response antibody titers IgG S Protein reference strain (ELISA) - Week 26 (Day 182) post Dose 2
|
10833.5 Titer
Interval 1763.7 to 66543.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group A Comirnaty
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group A BNT162b2s01
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Group A Total
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Group B Non-transplant Participants
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Group B Transplant Participants
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Group B Total
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Group B Immunology Subset Non-transplant Participants
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group B Immunology Subset Transplant Participants
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Group B Immunology Subset Total
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A Comirnaty
n=21 participants at risk
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 participants at risk
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 participants at risk
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=61 participants at risk
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=11 participants at risk
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
n=72 participants at risk
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
n=22 participants at risk
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
n=11 participants at risk
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
n=33 participants at risk
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
2.3%
1/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.5%
1/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.6%
1/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Injury, poisoning and procedural complications
Shunt blood flow excessive
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
2.3%
1/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.5%
1/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
Other adverse events
| Measure |
Group A Comirnaty
n=21 participants at risk
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
|
Group A BNT162b2s01
n=44 participants at risk
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
|
Group A Total
n=65 participants at risk
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
|
Group B Non-transplant Participants
n=61 participants at risk
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Transplant Participants
n=11 participants at risk
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Total
n=72 participants at risk
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Non-transplant Participants
n=22 participants at risk
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
Group B Immunology Subset Transplant Participants
n=11 participants at risk
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
|
Group B Immunology Subset Total
n=33 participants at risk
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
General disorders
Fatigue
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
4.5%
2/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.1%
2/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.6%
1/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
2.8%
2/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
4.5%
1/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
6.1%
2/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
General disorders
Pyrexia
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
6.8%
3/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
6.2%
4/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.6%
1/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
27.3%
3/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
5.6%
4/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
4.5%
1/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
27.3%
3/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
12.1%
4/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
2.3%
1/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
4.6%
3/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.4%
1/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
1/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.0%
1/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
2.3%
1/44 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
1.5%
1/65 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
3.3%
2/61 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
2.8%
2/72 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
9.1%
2/22 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
0.00%
0/11 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
6.1%
2/33 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
|
Additional Information
BioNTech clinical trials patient information
BioNTech SE
Phone: +49 6131 9084
Email: [email protected]
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