Trial Outcomes & Findings for A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults (NCT NCT04537949)
NCT ID: NCT04537949
Last Updated: 2024-01-05
Results Overview
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and 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 reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
96 participants
Primary outcome timeframe
From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization
Results posted on
2024-01-05
Participant Flow
Study participants were selected from the volunteer panel at the clinical CRO, volunteers who responded to either generic or study-specific advertisements in social media, or volunteers who contacted the clinical CRO via a web-based study participant recruitment portal. Study participants were selected from this pool of volunteers according to inclusion and exclusion criteria. The first participant was enrolled on 09 Sep 2020. The last visit of the last participant was on 07 Feb 2022.
All enrolled participants were allocated to treatment.
Participant milestones
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).
|
Part A Participants Aged 56 to 85 Years - 3 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Phase
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Treatment Phase
COMPLETED
|
11
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Treatment Phase
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Phase
STARTED
|
11
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Follow-up Phase
COMPLETED
|
8
|
8
|
12
|
9
|
9
|
11
|
7
|
6
|
|
Follow-up Phase
NOT COMPLETED
|
3
|
4
|
0
|
3
|
3
|
1
|
5
|
6
|
Reasons for withdrawal
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).
|
Part A Participants Aged 56 to 85 Years - 3 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Phase
personal reasons not related to the IMP
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Phase
Roll-over into trial BNT162-14
|
3
|
1
|
0
|
2
|
1
|
1
|
5
|
6
|
|
Follow-up Phase
Lost to Follow-up
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Phase
personal reasons
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Follow-up Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.32 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
31.20 years
STANDARD_DEVIATION 9.11 • n=7 Participants
|
31.89 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
37.28 years
STANDARD_DEVIATION 6.40 • n=4 Participants
|
66.08 years
STANDARD_DEVIATION 7.16 • n=21 Participants
|
69.32 years
STANDARD_DEVIATION 8.74 • n=8 Participants
|
64.93 years
STANDARD_DEVIATION 6.63 • n=8 Participants
|
66.42 years
STANDARD_DEVIATION 6.82 • n=24 Participants
|
50.80 years
STANDARD_DEVIATION 18.28 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
54 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
42 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
96 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
95 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
12 participants
n=8 Participants
|
12 participants
n=8 Participants
|
12 participants
n=24 Participants
|
96 participants
n=42 Participants
|
|
Weight
|
72.74 kg
STANDARD_DEVIATION 11.43 • n=5 Participants
|
71.68 kg
STANDARD_DEVIATION 11.67 • n=7 Participants
|
71.40 kg
STANDARD_DEVIATION 14.40 • n=5 Participants
|
71.02 kg
STANDARD_DEVIATION 13.80 • n=4 Participants
|
76.05 kg
STANDARD_DEVIATION 11.88 • n=21 Participants
|
70.90 kg
STANDARD_DEVIATION 10.69 • n=8 Participants
|
69.06 kg
STANDARD_DEVIATION 14.25 • n=8 Participants
|
84.43 kg
STANDARD_DEVIATION 17.53 • n=24 Participants
|
73.41 kg
STANDARD_DEVIATION 13.66 • n=42 Participants
|
|
Body mass index
|
23.89 kg/m^2
STANDARD_DEVIATION 2.92 • n=5 Participants
|
24.23 kg/m^2
STANDARD_DEVIATION 3.68 • n=7 Participants
|
23.80 kg/m^2
STANDARD_DEVIATION 2.74 • n=5 Participants
|
23.69 kg/m^2
STANDARD_DEVIATION 2.03 • n=4 Participants
|
25.92 kg/m^2
STANDARD_DEVIATION 1.66 • n=21 Participants
|
24.69 kg/m^2
STANDARD_DEVIATION 3.09 • n=8 Participants
|
24.03 kg/m^2
STANDARD_DEVIATION 3.17 • n=8 Participants
|
26.73 kg/m^2
STANDARD_DEVIATION 2.75 • n=24 Participants
|
24.62 kg/m^2
STANDARD_DEVIATION 2.91 • n=42 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost ImmunizationPopulation: Safety Set - All participants who received at least one dose of the IMP.
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and 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 reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose
Boost up to Day 7 after Boost: Number of participants with any grade >= 3 local reaction
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose
Prime up to Day 7 after Prime: Number of participants with any local reaction
|
9 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
4 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose
Prime up to Day 7 after Prime: Number of participants with any grade >= 3 local reaction
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose
Boost up to Day 7 after Boost: Number of participants with any local reaction
|
9 Participants
|
9 Participants
|
12 Participants
|
—
|
2 Participants
|
9 Participants
|
8 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost ImmunizationPopulation: Safety Set - All participants who received at least one dose of the IMP.
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and 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 reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose
Prime up to Day 7 after Prime: Number of participants with any systemic reaction
|
4 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
3 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose
Boost up to Day 7 after Boost: Number of participants with any systemic reaction
|
10 Participants
|
9 Participants
|
12 Participants
|
—
|
2 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose
Boost up to Day 7 after Boost: Number of participants with any grade >= 3 systemic reaction
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose
Prime up to Day 7 after Prime: Number of participants with any grade >= 3 systemic reaction
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 28 days following first IMP dose or up to second IMP dose (whichever was first)Population: Safety Set - All participants who received at least one dose of the IMP.
Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The number and percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization
Any TEAE
|
42 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
50 percentage of participants
|
17 percentage of participants
|
17 percentage of participants
|
25 percentage of participants
|
42 percentage of participants
|
|
The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization
Any grade >=3 TEAE
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 28 days following second IMP dose or first IMP dose (if no second IMP dose as given)Population: Safety Set - All participants who received at least one dose of the IMP.
Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization)
Any TEAE
|
50 percentage of participants
|
33 percentage of participants
|
42 percentage of participants
|
50 percentage of participants
|
58 percentage of participants
|
25 percentage of participants
|
42 percentage of participants
|
50 percentage of participants
|
|
The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization)
Any grade >=3 TEAE
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8 percentage of participants
|
SECONDARY outcome
Timeframe: up to 50 days following first IMP dosePopulation: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision.
At 7 and 21 days after primary immunization and at 7, 14, 21, 28 days after boost immunization.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Functional Antibody Responses
7 days after Prime Immunization (Day 8)
|
5.0 titer
Interval 5.0 to 5.0
|
5.1 titer
Interval 4.8 to 5.5
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
7.3 titer
Interval 3.2 to 16.6
|
5.0 titer
Interval 5.0 to 5.0
|
|
Functional Antibody Responses
14 days after Boost Immunization (Day 36)
|
60.6 titer
Interval 33.5 to 109.8
|
NA titer
Missing Day 36 data of 10 μg younger cohort as they have only re-consented to Clinical Trial Protocol 7.0 (introducing visit 5a/Day 36) on/after their Day 43.
|
NA titer
Missing Day 36 data of 20 μg younger cohort as they have only re-consented to Clinical Trial Protocol 7.0 (introducing visit 5a/Day 36) on/after their Day 43.
|
10.3 titer
Interval 6.9 to 15.4
|
77.7 titer
Interval 40.4 to 149.4
|
219.8 titer
Interval 148.5 to 325.4
|
320.0 titer
Interval 169.3 to 604.9
|
359.2 titer
Interval 204.0 to 632.6
|
|
Functional Antibody Responses
21 days after Boost Immunization (Day 43)
|
36.4 titer
Interval 20.0 to 66.2
|
116.5 titer
Interval 79.6 to 170.4
|
201.6 titer
Interval 104.9 to 387.2
|
9.7 titer
Interval 5.7 to 16.5
|
53.4 titer
Interval 27.5 to 103.6
|
155.4 titer
Interval 105.0 to 230.1
|
285.1 titer
Interval 152.6 to 532.7
|
261.4 titer
Interval 136.0 to 502.6
|
|
Functional Antibody Responses
28 days after Boost Immunization (Day 50)
|
31.7 titer
Interval 18.5 to 54.6
|
80.0 titer
Interval 49.1 to 130.4
|
219.8 titer
Interval 117.5 to 411.1
|
7.9 titer
Interval 5.0 to 12.5
|
41.2 titer
Interval 20.5 to 82.8
|
138.5 titer
Interval 87.9 to 218.2
|
232.9 titer
Interval 131.1 to 413.8
|
195.8 titer
Interval 109.4 to 350.6
|
|
Functional Antibody Responses
21 days after Prime Immunization (Day 22)
|
6.1 titer
Interval 4.5 to 8.4
|
25.9 titer
Interval 13.8 to 48.7
|
8.9 titer
Interval 6.0 to 13.3
|
12.2 titer
Interval 7.5 to 20.0
|
6.3 titer
Interval 4.8 to 8.3
|
5.3 titer
Interval 4.9 to 5.8
|
15.0 titer
Interval 5.9 to 37.9
|
9.4 titer
Interval 5.4 to 16.4
|
|
Functional Antibody Responses
7 days after Boost Immunization (Day 29)
|
51.5 titer
Interval 26.4 to 100.3
|
479.5 titer
Interval 300.3 to 765.5
|
106.8 titer
Interval 58.2 to 196.0
|
10.0 titer
Interval 6.5 to 15.4
|
53.4 titer
Interval 25.1 to 113.7
|
51.9 titer
Interval 25.0 to 107.4
|
320.0 titer
Interval 189.7 to 539.7
|
207.5 titer
Interval 118.0 to 364.8
|
SECONDARY outcome
Timeframe: up to 50 days following first IMP dosePopulation: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision.
At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Fold Increase in Functional Antibody Titers
21 days after Prime Immunization (Day 22)
|
1.2 Fold rise
Interval 0.9 to 1.7
|
5.2 Fold rise
Interval 2.8 to 9.7
|
1.8 Fold rise
Interval 1.2 to 2.7
|
2.4 Fold rise
Interval 1.5 to 4.0
|
1.3 Fold rise
Interval 1.0 to 1.7
|
1.1 Fold rise
Interval 1.0 to 1.2
|
2.6 Fold rise
Interval 1.3 to 5.0
|
1.9 Fold rise
Interval 1.1 to 3.3
|
|
Fold Increase in Functional Antibody Titers
7 days after Boost Immunization (Day 29)
|
10.3 Fold rise
Interval 5.3 to 20.1
|
95.9 Fold rise
Interval 60.1 to 153.1
|
21.4 Fold rise
Interval 11.6 to 39.2
|
2.0 Fold rise
Interval 1.3 to 3.1
|
10.7 Fold rise
Interval 5.0 to 22.7
|
10.4 Fold rise
Interval 5.0 to 21.5
|
55.4 Fold rise
Interval 35.5 to 86.4
|
41.5 Fold rise
Interval 23.6 to 73.0
|
|
Fold Increase in Functional Antibody Titers
14 days after Boost Immunization (Day 36)
|
12.1 Fold rise
Interval 6.7 to 22.0
|
—
|
—
|
2.1 Fold rise
Interval 1.4 to 3.1
|
15.5 Fold rise
Interval 8.1 to 29.9
|
44.0 Fold rise
Interval 29.7 to 65.1
|
55.4 Fold rise
Interval 31.2 to 98.4
|
71.8 Fold rise
Interval 40.8 to 126.5
|
|
Fold Increase in Functional Antibody Titers
21 days after Boost Immunization (Day 43)
|
7.3 Fold rise
Interval 4.0 to 13.2
|
23.3 Fold rise
Interval 15.9 to 34.1
|
40.3 Fold rise
Interval 21.0 to 77.4
|
1.9 Fold rise
Interval 1.1 to 3.3
|
10.7 Fold rise
Interval 5.5 to 20.7
|
31.1 Fold rise
Interval 21.0 to 46.0
|
49.4 Fold rise
Interval 29.7 to 81.9
|
52.3 Fold rise
Interval 27.2 to 100.5
|
|
Fold Increase in Functional Antibody Titers
28 days after Boost Immunization (Day 50)
|
6.3 Fold rise
Interval 3.7 to 10.9
|
16.0 Fold rise
Interval 9.8 to 26.1
|
44.0 Fold rise
Interval 23.5 to 82.2
|
1.6 Fold rise
Interval 1.0 to 2.5
|
8.2 Fold rise
Interval 4.1 to 16.6
|
27.7 Fold rise
Interval 17.6 to 43.6
|
40.3 Fold rise
Interval 26.7 to 60.9
|
39.2 Fold rise
Interval 21.9 to 70.1
|
|
Fold Increase in Functional Antibody Titers
7 days after Prime Immunization (Day 8)
|
1.0 Fold rise
Interval 1.0 to 1.0
|
1.0 Fold rise
Interval 1.0 to 1.1
|
1.0 Fold rise
Interval 1.0 to 1.0
|
1.0 Fold rise
Interval 1.0 to 1.0
|
1.0 Fold rise
Interval 1.0 to 1.0
|
1.0 Fold rise
Interval 1.0 to 1.0
|
1.3 Fold rise
Interval 0.8 to 2.1
|
1.0 Fold rise
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: up to 50 days following first IMP dosePopulation: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision.
At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
7 days after Prime Immunization (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
21 days after Prime Immunization (Day 22)
|
1 Participants
|
9 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
14 days after Boost Immunization (Day 36)
|
9 Participants
|
—
|
—
|
4 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
21 days after Boost Immunization (Day 43)
|
8 Participants
|
12 Participants
|
12 Participants
|
3 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
28 days after Boost Immunization (Day 50)
|
8 Participants
|
11 Participants
|
12 Participants
|
1 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
7 days after Boost Immunization (Day 29)
|
9 Participants
|
12 Participants
|
12 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From 51 to up to 387 days following first IMP dosePopulation: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. Day 387 (365 days after boost) data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation.
At 63, 162, 365 days after boost immunization.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Functional Antibody Responses
63 days after Boost Immunization (Day 85)
|
40.0 titer
Interval 22.4 to 71.4
|
51.9 titer
Interval 39.1 to 68.9
|
116.5 titer
Interval 51.0 to 266.1
|
13.0 titer
Interval 7.8 to 21.5
|
34.6 titer
Interval 18.1 to 66.1
|
85.2 titer
Interval 48.7 to 149.0
|
142.5 titer
Interval 77.9 to 260.7
|
75.5 titer
Interval 45.6 to 125.0
|
|
Functional Antibody Responses
162 days after Boost Immunization (Day 184)
|
11.7 titer
Interval 5.8 to 23.8
|
51.5 titer
Interval 33.9 to 78.1
|
119.9 titer
Interval 62.6 to 229.5
|
11.0 titer
Interval 4.7 to 25.8
|
9.6 titer
Interval 6.1 to 15.0
|
28.3 titer
Interval 11.2 to 71.6
|
44.9 titer
Interval 22.0 to 91.8
|
107.7 titer
Interval 42.3 to 273.8
|
|
Functional Antibody Responses
365 days after Boost Immunization (Day 387)
|
197.0 titer
Interval 14.2 to 2727.9
|
452.5 titer
Interval 47.4 to 4322.3
|
513.3 titer
Interval 215.8 to 1221.2
|
5.0 titer
Confidence intervals were only calculated if values of at least 3 participants were available
|
1280.0 titer
Confidence intervals were only calculated if values of at least 3 participants were available
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 51 to up to 387 days following first IMP dosePopulation: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. Day 387 (365 days after boost) data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation.
At 63, 162, 365 days after boost immunization.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Fold Increase in Functional Antibody Titers
162 days after Boost Immunization (Day 184)
|
2.3 Fold rise
Interval 1.2 to 4.8
|
10.3 Fold rise
Interval 6.8 to 15.6
|
24.0 Fold rise
Interval 12.5 to 45.9
|
2.2 Fold rise
Interval 0.9 to 5.2
|
1.9 Fold rise
Interval 1.2 to 3.0
|
5.7 Fold rise
Interval 2.2 to 14.3
|
9.0 Fold rise
Interval 4.4 to 18.4
|
21.5 Fold rise
Interval 8.5 to 54.8
|
|
Fold Increase in Functional Antibody Titers
365 days after Boost Immunization (Day 387)
|
39.4 Fold rise
Interval 2.8 to 545.6
|
90.5 Fold rise
Interval 9.5 to 864.5
|
102.7 Fold rise
Interval 43.2 to 244.2
|
1.0 Fold rise
Confidence intervals were only calculated if values of at least 3 participants were available
|
256.0 Fold rise
Confidence intervals were only calculated if values of at least 3 participants were available
|
—
|
—
|
—
|
|
Fold Increase in Functional Antibody Titers
63 days after Boost Immunization (Day 85)
|
8.0 Fold rise
Interval 4.5 to 14.3
|
10.4 Fold rise
Interval 7.8 to 13.8
|
23.3 Fold rise
Interval 10.2 to 53.2
|
2.6 Fold rise
Interval 1.6 to 4.3
|
6.9 Fold rise
Interval 3.6 to 13.2
|
17.0 Fold rise
Interval 9.7 to 29.8
|
24.7 Fold rise
Interval 15.3 to 39.9
|
15.1 Fold rise
Interval 9.1 to 25.0
|
SECONDARY outcome
Timeframe: From 51 to up to 387 days following first IMP dosePopulation: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. Day 387 (365 days after boost) data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation.
At 63, 162, 365 days after boost immunization.
Outcome measures
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 Participants
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
365 days after Boost Immunization (Day 387)
|
4 Participants
|
5 Participants
|
11 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
63 days after Boost Immunization (Day 85)
|
9 Participants
|
12 Participants
|
11 Participants
|
3 Participants
|
8 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
162 days after Boost Immunization (Day 184)
|
4 Participants
|
11 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
Part A Participants Aged 18 to 55 Years - 3 μg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A Participants Aged 18 to 55 Years - 10 μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A Participants Aged 18 to 55 Years - 20 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A Participants Aged 18 to 55 Years - 30 μg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A Participants Aged 56 to 85 Years - 3 μg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A Participants Aged 56 to 85 Years - 10 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A Participants Aged 56 to 85 Years - 20 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A Participants Aged 56 to 85 Years - 30 μg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
Other adverse events
| Measure |
Part A Participants Aged 18 to 55 Years - 3 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 10 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 20 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 18 to 55 Years - 30 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
|
Part A Participants Aged 56 to 85 Years - 3 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 10 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 20 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
Part A Participants Aged 56 to 85 Years - 30 μg
n=12 participants at risk
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost \[P/B\] regimen)
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Eye disorders
Meibomian gland dysfunction
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
General disorders
Injection site reaction
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
General disorders
Malaise
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
General disorders
Tenderness
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Investigations
Lipase increased
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
16.7%
2/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
16.7%
2/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
16.7%
2/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
25.0%
3/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Psychiatric disorders
Sleep disorder
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
16.7%
2/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Surgical and medical procedures
Dental care
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
8.3%
1/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
0.00%
0/12 • Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
|
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 PIs 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