Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (NCT NCT05596734)
NCT ID: NCT05596734
Last Updated: 2025-07-23
Results Overview
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (\>) 2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1019 participants
Primary outcome timeframe
SSA: From Day 1 to Day 7 after Vaccination
Results posted on
2025-07-23
Participant Flow
There were 2 sub studies: Sub study A and Sub study B. A total of 1019 participants were enrolled, out of which 1009 participants were vaccinated (sub study A: 377 and sub study B: 632).
Interventions administered: quadrivalent influenza modRNA vaccine (qIRV), trivalent influenza modRNA vaccine (tIRV), Bivalent BNT162b2 (Original/Omi BA.4/BA.5) and quadrivalent influenza vaccine (QIV).
Participant milestones
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (\>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged \>=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged \>=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged \>=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and bIRV/Bivalent BNT162b2 (45 mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg)(OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV/Bivalent BNT162b2 (60 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV/Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV/Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy A
STARTED
|
30
|
28
|
30
|
30
|
30
|
32
|
33
|
32
|
33
|
33
|
33
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy A
COMPLETED
|
28
|
28
|
29
|
30
|
30
|
32
|
32
|
32
|
33
|
33
|
33
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy A
NOT COMPLETED
|
2
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy B
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
29
|
32
|
124
|
122
|
114
|
31
|
30
|
33
|
30
|
26
|
32
|
29
|
|
Substudy B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
27
|
32
|
122
|
118
|
112
|
30
|
28
|
33
|
30
|
26
|
32
|
28
|
|
Substudy B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
4
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (\>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged \>=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged \>=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged \>=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and bIRV/Bivalent BNT162b2 (45 mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg)(OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV/Bivalent BNT162b2 (60 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV/Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV/Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy A
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy A
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
2
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
|
Substudy B
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy B
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Baseline characteristics by cohort
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged greater than or equal to (\>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
n=32 Participants
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 30 mcg
n=33 Participants
Participants aged \>=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 60 mcg
n=33 Participants
Participants aged \>=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged \>=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
n=29 Participants
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
n=32 Participants
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=124 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=122 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 1)
n=114 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg)
n=31 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Total
n=1009 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.1 Years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
44.4 Years
STANDARD_DEVIATION 12.75 • n=7 Participants
|
43.1 Years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
42.9 Years
STANDARD_DEVIATION 10.53 • n=4 Participants
|
46.2 Years
STANDARD_DEVIATION 11.78 • n=21 Participants
|
40.5 Years
STANDARD_DEVIATION 12.70 • n=8 Participants
|
71.5 Years
STANDARD_DEVIATION 5.33 • n=8 Participants
|
71.2 Years
STANDARD_DEVIATION 5.53 • n=24 Participants
|
71.4 Years
STANDARD_DEVIATION 4.32 • n=42 Participants
|
70.8 Years
STANDARD_DEVIATION 4.27 • n=42 Participants
|
71.6 Years
STANDARD_DEVIATION 4.55 • n=42 Participants
|
71.7 Years
STANDARD_DEVIATION 4.67 • n=42 Participants
|
40.9 Years
STANDARD_DEVIATION 11.99 • n=36 Participants
|
44.1 Years
STANDARD_DEVIATION 12.86 • n=36 Participants
|
46.4 Years
STANDARD_DEVIATION 12.13 • n=24 Participants
|
45.9 Years
STANDARD_DEVIATION 12.56 • n=135 Participants
|
44.9 Years
STANDARD_DEVIATION 14.25 • n=136 Participants
|
47.0 Years
STANDARD_DEVIATION 11.64 • n=44 Participants
|
48.6 Years
STANDARD_DEVIATION 10.17 • n=667 Participants
|
47.1 Years
STANDARD_DEVIATION 11.79 • n=15 Participants
|
47.9 Years
STANDARD_DEVIATION 9.75 • n=40 Participants
|
46.9 Years
STANDARD_DEVIATION 12.96 • n=40 Participants
|
46.0 Years
STANDARD_DEVIATION 11.93 • n=41 Participants
|
47.1 Years
STANDARD_DEVIATION 12.94 • n=600 Participants
|
58.2 Years
STANDARD_DEVIATION 16.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
20 Participants
n=36 Participants
|
84 Participants
n=24 Participants
|
74 Participants
n=135 Participants
|
59 Participants
n=136 Participants
|
19 Participants
n=44 Participants
|
23 Participants
n=667 Participants
|
20 Participants
n=15 Participants
|
18 Participants
n=40 Participants
|
16 Participants
n=40 Participants
|
22 Participants
n=41 Participants
|
13 Participants
n=600 Participants
|
579 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
40 Participants
n=24 Participants
|
48 Participants
n=135 Participants
|
55 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
13 Participants
n=15 Participants
|
12 Participants
n=40 Participants
|
10 Participants
n=40 Participants
|
10 Participants
n=41 Participants
|
16 Participants
n=600 Participants
|
430 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
18 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
47 Participants
n=24 Participants
|
42 Participants
n=135 Participants
|
47 Participants
n=136 Participants
|
11 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
10 Participants
n=15 Participants
|
9 Participants
n=40 Participants
|
8 Participants
n=40 Participants
|
12 Participants
n=41 Participants
|
9 Participants
n=600 Participants
|
432 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
77 Participants
n=24 Participants
|
79 Participants
n=135 Participants
|
67 Participants
n=136 Participants
|
20 Participants
n=44 Participants
|
22 Participants
n=667 Participants
|
23 Participants
n=15 Participants
|
21 Participants
n=40 Participants
|
18 Participants
n=40 Participants
|
20 Participants
n=41 Participants
|
20 Participants
n=600 Participants
|
571 Participants
n=4 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
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
6 Participants
n=4 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=600 Participants
|
51 Participants
n=4 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
12 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
6 Participants
n=15 Participants
|
7 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
5 Participants
n=41 Participants
|
3 Participants
n=600 Participants
|
103 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
24 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
100 Participants
n=24 Participants
|
104 Participants
n=135 Participants
|
95 Participants
n=136 Participants
|
28 Participants
n=44 Participants
|
22 Participants
n=667 Participants
|
24 Participants
n=15 Participants
|
19 Participants
n=40 Participants
|
14 Participants
n=40 Participants
|
25 Participants
n=41 Participants
|
22 Participants
n=600 Participants
|
839 Participants
n=4 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=600 Participants
|
7 Participants
n=4 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (\>) 2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)
|
83.3 Percentage of participants
Interval 65.3 to 94.4
|
89.3 Percentage of participants
Interval 71.8 to 97.7
|
80.0 Percentage of participants
Interval 61.4 to 92.3
|
63.3 Percentage of participants
Interval 43.9 to 80.1
|
73.3 Percentage of participants
Interval 54.1 to 87.7
|
71.9 Percentage of participants
Interval 53.3 to 86.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years)
|
84.8 Percentage of participants
Interval 68.1 to 94.9
|
53.1 Percentage of participants
Interval 34.7 to 70.9
|
84.8 Percentage of participants
Interval 68.1 to 94.9
|
63.6 Percentage of participants
Interval 45.1 to 79.6
|
72.7 Percentage of participants
Interval 54.5 to 86.7
|
51.5 Percentage of participants
Interval 33.5 to 69.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature \>=38.0 deg C and categorized as\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: \>2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years)
|
76.7 Percentage of participants
Interval 57.7 to 90.1
|
78.6 Percentage of participants
Interval 59.0 to 91.7
|
70.0 Percentage of participants
Interval 50.6 to 85.3
|
53.3 Percentage of participants
Interval 34.3 to 71.7
|
63.3 Percentage of participants
Interval 43.9 to 80.1
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature \>=38.0 deg C and categorized as\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: \>2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years)
|
72.7 Percentage of participants
Interval 54.5 to 86.7
|
50.0 Percentage of participants
Interval 31.9 to 68.1
|
69.7 Percentage of participants
Interval 51.3 to 84.4
|
45.5 Percentage of participants
Interval 28.1 to 63.6
|
60.6 Percentage of participants
Interval 42.1 to 77.1
|
45.5 Percentage of participants
Interval 28.1 to 63.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: From Vaccination on Day 1 through 4 Weeks after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years)
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
10.7 Percentage of participants
Interval 2.3 to 28.2
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: From Vaccination on Day 1 through 4 Weeks after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years)
|
24.2 Percentage of participants
Interval 11.1 to 42.3
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
6.1 Percentage of participants
Interval 0.7 to 20.2
|
6.1 Percentage of participants
Interval 0.7 to 20.2
|
9.1 Percentage of participants
Interval 1.9 to 24.3
|
0 Percentage of participants
Interval 0.0 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: From Vaccination on Day 1 through 6 Months after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.6 Percentage of participants
Interval 0.1 to 18.3
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: From Vaccination on Day 1 through 6 Months after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years)
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 10.6
|
6.1 Percentage of participants
Interval 0.7 to 20.2
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 2 Days after VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=30 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years)
|
0 Percentage of participants
Interval 0.0 to 12.3
|
0 Percentage of participants
Interval 0.0 to 12.3
|
0 Percentage of participants
Interval 0.0 to 12.3
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 2 Days after VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment to which they were received.
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=31 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years)
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 1 Week After VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years)
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
0 Percentage of participants
Interval 0.0 to 13.2
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 1 Week After VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=31 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years)
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 2 Days after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 12.3
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 2 Days after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years)
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 1 Week after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 12.3
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSA: 1 Week after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=33 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years)
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SSB: 2 Days after VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=123 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=122 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=113 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=28 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 13.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 12.3
|
PRIMARY outcome
Timeframe: SSB: 1 Week after VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=121 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=120 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=111 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=30 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=28 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.3
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 13.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 12.3
|
PRIMARY outcome
Timeframe: SSB: 2 Days after VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=123 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=122 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=113 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=28 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 13.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 12.3
|
PRIMARY outcome
Timeframe: SSB: 1 Week after VaccinationPopulation: Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=123 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=122 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=113 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=28 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 13.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 12.3
|
PRIMARY outcome
Timeframe: SSB: From Day 1 to Day 7 after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=124 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=122 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=114 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years)
|
58.6 Percentage of participants
Interval 38.9 to 76.5
|
71.9 Percentage of participants
Interval 53.3 to 86.3
|
78.2 Percentage of participants
Interval 69.9 to 85.1
|
82.8 Percentage of participants
Interval 74.9 to 89.0
|
75.4 Percentage of participants
Interval 66.5 to 83.0
|
80.6 Percentage of participants
Interval 62.5 to 92.5
|
80.0 Percentage of participants
Interval 61.4 to 92.3
|
81.8 Percentage of participants
Interval 64.5 to 93.0
|
66.7 Percentage of participants
Interval 47.2 to 82.7
|
73.1 Percentage of participants
Interval 52.2 to 88.4
|
71.9 Percentage of participants
Interval 53.3 to 86.3
|
69.0 Percentage of participants
Interval 49.2 to 84.7
|
PRIMARY outcome
Timeframe: SSB: From Day 1 to Day 7 after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature \>=38.0 deg C and categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: \>2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=124 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=122 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=114 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years)
|
51.7 Percentage of participants
Interval 32.5 to 70.6
|
62.5 Percentage of participants
Interval 43.7 to 78.9
|
74.2 Percentage of participants
Interval 65.6 to 81.6
|
77.0 Percentage of participants
Interval 68.6 to 84.2
|
71.1 Percentage of participants
Interval 61.8 to 79.2
|
80.6 Percentage of participants
Interval 62.5 to 92.5
|
80.0 Percentage of participants
Interval 61.4 to 92.3
|
72.7 Percentage of participants
Interval 54.5 to 86.7
|
73.3 Percentage of participants
Interval 54.1 to 87.7
|
65.4 Percentage of participants
Interval 44.3 to 82.8
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
48.3 Percentage of participants
Interval 29.4 to 67.5
|
PRIMARY outcome
Timeframe: SSB: From Vaccination on Day 1 through 4 Weeks after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=124 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=122 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=114 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.9
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
4.8 Percentage of participants
Interval 1.8 to 10.2
|
6.6 Percentage of participants
Interval 2.9 to 12.5
|
6.1 Percentage of participants
Interval 2.5 to 12.2
|
9.7 Percentage of participants
Interval 2.0 to 25.8
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
6.1 Percentage of participants
Interval 0.7 to 20.2
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
0 Percentage of participants
Interval 0.0 to 13.2
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
0 Percentage of participants
Interval 0.0 to 11.9
|
PRIMARY outcome
Timeframe: SSB: From Vaccination on Day 1 through 6 Months after VaccinationPopulation: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=124 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=122 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=114 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years)
|
0 Percentage of participants
Interval 0.0 to 11.9
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
3.2 Percentage of participants
Interval 0.1 to 16.7
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 10.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 13.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 11.9
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination and 4 Weeks after VaccinationPopulation: Evaluable immunogenicity population (EIP) included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: Before vaccination
|
32.0 Titers
Interval 16.6 to 61.8
|
14.7 Titers
Interval 8.8 to 24.7
|
31.2 Titers
Interval 18.4 to 53.0
|
26.0 Titers
Interval 16.6 to 40.7
|
16.4 Titers
Interval 9.5 to 28.2
|
34.2 Titers
Interval 19.5 to 59.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: 4 Weeks after vaccination
|
341.6 Titers
Interval 226.5 to 515.4
|
201.6 Titers
Interval 121.0 to 335.8
|
282.7 Titers
Interval 164.3 to 486.5
|
259.9 Titers
Interval 177.9 to 379.8
|
249.8 Titers
Interval 153.6 to 406.3
|
294.7 Titers
Interval 184.9 to 469.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: Before vaccination
|
32.0 Titers
Interval 18.9 to 54.3
|
31.2 Titers
Interval 18.5 to 52.5
|
30.9 Titers
Interval 20.1 to 47.6
|
23.6 Titers
Interval 15.0 to 37.3
|
16.4 Titers
Interval 10.1 to 26.8
|
36.6 Titers
Interval 25.6 to 52.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: 4 Weeks after vaccination
|
14.9 Titers
Interval 9.5 to 23.2
|
20.0 Titers
Interval 12.4 to 32.4
|
18.6 Titers
Interval 11.7 to 29.4
|
17.8 Titers
Interval 11.2 to 28.3
|
20.0 Titers
Interval 12.0 to 33.2
|
40.0 Titers
Interval 24.8 to 64.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: Before vaccination
|
18.1 Titers
Interval 12.0 to 27.3
|
16.7 Titers
Interval 10.5 to 26.5
|
12.8 Titers
Interval 8.5 to 19.4
|
21.0 Titers
Interval 13.3 to 33.1
|
12.2 Titers
Interval 8.6 to 17.3
|
24.5 Titers
Interval 16.2 to 36.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: 4 Weeks after vaccination
|
165.5 Titers
Interval 101.0 to 271.2
|
141.9 Titers
Interval 83.1 to 242.2
|
160.0 Titers
Interval 102.5 to 249.7
|
167.6 Titers
Interval 120.2 to 233.7
|
129.1 Titers
Interval 77.9 to 213.7
|
97.8 Titers
Interval 62.9 to 152.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: Before vaccination
|
10.5 Titers
Interval 7.0 to 15.8
|
12.0 Titers
Interval 7.4 to 19.3
|
11.0 Titers
Interval 7.2 to 16.9
|
9.8 Titers
Interval 6.7 to 14.1
|
10.5 Titers
Interval 7.1 to 15.6
|
12.0 Titers
Interval 7.9 to 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: 4 Weeks after vaccination
|
26.9 Titers
Interval 17.3 to 41.9
|
36.1 Titers
Interval 24.2 to 53.9
|
35.3 Titers
Interval 22.6 to 55.2
|
45.9 Titers
Interval 30.0 to 70.4
|
41.0 Titers
Interval 27.9 to 60.2
|
78.2 Titers
Interval 55.5 to 110.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination and 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Darwin: 4 Weeks after vaccination
|
107.5 Titers
Interval 75.4 to 153.3
|
115.6 Titers
Interval 84.7 to 157.8
|
134.5 Titers
Interval 96.2 to 188.3
|
81.8 Titers
Interval 61.2 to 109.3
|
181.7 Titers
Interval 120.5 to 274.1
|
83.5 Titers
Interval 57.4 to 121.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Austria: Before vaccination
|
37.5 Titers
Interval 26.9 to 52.2
|
28.3 Titers
Interval 17.4 to 45.9
|
27.1 Titers
Interval 18.8 to 39.0
|
28.0 Titers
Interval 18.2 to 43.0
|
44.0 Titers
Interval 28.9 to 67.1
|
22.8 Titers
Interval 16.5 to 31.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Austria: 4 Weeks after vaccination
|
49.7 Titers
Interval 37.8 to 65.2
|
44.6 Titers
Interval 28.8 to 68.9
|
40.9 Titers
Interval 29.3 to 57.0
|
40.9 Titers
Interval 28.6 to 58.4
|
64.5 Titers
Interval 44.7 to 93.1
|
41.8 Titers
Interval 32.7 to 53.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Phuket: 4 Weeks after vaccination
|
20.0 Titers
Interval 15.1 to 26.6
|
14.5 Titers
Interval 10.8 to 19.3
|
20.4 Titers
Interval 14.2 to 29.5
|
15.0 Titers
Interval 11.1 to 20.2
|
26.0 Titers
Interval 18.0 to 37.6
|
15.4 Titers
Interval 11.0 to 21.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Wisconsin: Before vaccination
|
56.6 Titers
Interval 35.5 to 90.2
|
38.3 Titers
Interval 24.3 to 60.3
|
57.8 Titers
Interval 36.1 to 92.6
|
53.5 Titers
Interval 36.1 to 79.2
|
69.3 Titers
Interval 45.1 to 106.6
|
50.8 Titers
Interval 34.2 to 75.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Wisconsin: 4 Weeks after vaccination
|
113.1 Titers
Interval 73.9 to 173.2
|
97.2 Titers
Interval 69.0 to 137.0
|
156.6 Titers
Interval 97.6 to 251.2
|
119.6 Titers
Interval 82.6 to 173.2
|
150.1 Titers
Interval 95.2 to 236.6
|
80.0 Titers
Interval 56.8 to 112.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Darwin: Before vaccination
|
57.2 Titers
Interval 38.6 to 84.8
|
40.9 Titers
Interval 31.3 to 53.3
|
62.0 Titers
Interval 46.7 to 82.4
|
41.8 Titers
Interval 29.6 to 59.2
|
71.0 Titers
Interval 52.2 to 96.6
|
56.6 Titers
Interval 37.3 to 85.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Phuket: Before vaccination
|
14.8 Titers
Interval 10.8 to 20.3
|
11.9 Titers
Interval 8.9 to 15.9
|
12.4 Titers
Interval 8.7 to 17.6
|
10.7 Titers
Interval 8.0 to 14.3
|
15.0 Titers
Interval 10.6 to 21.3
|
10.4 Titers
Interval 7.9 to 13.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination to 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
B/Phuket
|
1.3 Fold Rise
Interval 1.0 to 1.8
|
1.8 Fold Rise
Interval 1.4 to 2.4
|
2.2 Fold Rise
Interval 1.6 to 3.1
|
1.9 Fold Rise
Interval 1.5 to 2.5
|
2.6 Fold Rise
Interval 1.9 to 3.6
|
2.7 Fold Rise
Interval 2.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
B/Austria
|
1.2 Fold Rise
Interval 0.9 to 1.6
|
1.3 Fold Rise
Interval 1.1 to 1.7
|
1.4 Fold Rise
Interval 1.0 to 1.9
|
1.7 Fold Rise
Interval 1.2 to 2.3
|
1.6 Fold Rise
Interval 1.1 to 2.2
|
2.6 Fold Rise
Interval 1.7 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin
|
8.5 Fold Rise
Interval 4.8 to 15.2
|
9.8 Fold Rise
Interval 5.7 to 16.8
|
8.2 Fold Rise
Interval 3.9 to 17.2
|
9.7 Fold Rise
Interval 5.9 to 15.9
|
11.0 Fold Rise
Interval 6.7 to 18.1
|
7.5 Fold Rise
Interval 4.1 to 13.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
A/Darwin
|
4.1 Fold Rise
Interval 2.7 to 6.3
|
3.9 Fold Rise
Interval 2.5 to 6.1
|
4.7 Fold Rise
Interval 3.0 to 7.3
|
5.9 Fold Rise
Interval 3.9 to 8.8
|
5.7 Fold Rise
Interval 3.8 to 8.6
|
2.5 Fold Rise
Interval 1.7 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination to 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
A/Darwin
|
1.8 Fold Rise
Interval 1.5 to 2.2
|
2.8 Fold Rise
Interval 2.1 to 3.7
|
2.1 Fold Rise
Interval 1.7 to 2.7
|
1.9 Fold Rise
Interval 1.5 to 2.3
|
2.6 Fold Rise
Interval 1.9 to 3.5
|
1.4 Fold Rise
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
B/Phuket
|
1.2 Fold Rise
Interval 1.1 to 1.4
|
1.1 Fold Rise
Interval 1.0 to 1.3
|
1.4 Fold Rise
Interval 1.1 to 1.6
|
1.2 Fold Rise
Interval 1.1 to 1.4
|
1.5 Fold Rise
Interval 1.2 to 1.9
|
1.4 Fold Rise
Interval 1.1 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
A/Wisconsin
|
2.0 Fold Rise
Interval 1.6 to 2.4
|
2.3 Fold Rise
Interval 1.8 to 3.0
|
2.7 Fold Rise
Interval 2.1 to 3.4
|
2.2 Fold Rise
Interval 1.7 to 2.9
|
2.2 Fold Rise
Interval 1.7 to 2.7
|
1.5 Fold Rise
Interval 1.1 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
B/Austria
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.4 Fold Rise
Interval 1.1 to 1.8
|
1.7 Fold Rise
Interval 1.3 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations."Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin
|
63.0 Percentage of participants
Interval 42.4 to 80.6
|
60.0 Percentage of participants
Interval 38.7 to 78.9
|
70.4 Percentage of participants
Interval 49.8 to 86.2
|
69.0 Percentage of participants
Interval 49.2 to 84.7
|
75.0 Percentage of participants
Interval 55.1 to 89.3
|
35.5 Percentage of participants
Interval 19.2 to 54.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin
|
75.0 Percentage of participants
Interval 55.1 to 89.3
|
77.8 Percentage of participants
Interval 57.7 to 91.4
|
71.4 Percentage of participants
Interval 51.3 to 86.8
|
86.2 Percentage of participants
Interval 68.3 to 96.1
|
89.3 Percentage of participants
Interval 71.8 to 97.7
|
61.3 Percentage of participants
Interval 42.2 to 78.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
B/Austria
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
3.7 Percentage of participants
Interval 0.1 to 19.0
|
21.4 Percentage of participants
Interval 8.3 to 41.0
|
17.2 Percentage of participants
Interval 5.8 to 35.8
|
25.0 Percentage of participants
Interval 10.7 to 44.9
|
38.7 Percentage of participants
Interval 21.8 to 57.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket
|
17.9 Percentage of participants
Interval 6.1 to 36.9
|
18.5 Percentage of participants
Interval 6.3 to 38.1
|
32.1 Percentage of participants
Interval 15.9 to 52.4
|
34.5 Percentage of participants
Interval 17.9 to 54.3
|
50.0 Percentage of participants
Interval 30.6 to 69.4
|
38.7 Percentage of participants
Interval 21.8 to 57.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)
A/Wisconsin
|
15.6 Percentage of participants
Interval 5.3 to 32.8
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
46.9 Percentage of participants
Interval 29.1 to 65.3
|
32.3 Percentage of participants
Interval 16.7 to 51.4
|
34.5 Percentage of participants
Interval 17.9 to 54.3
|
12.5 Percentage of participants
Interval 3.5 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)
A/Darwin
|
12.9 Percentage of participants
Interval 3.6 to 29.8
|
43.8 Percentage of participants
Interval 26.4 to 62.3
|
30.0 Percentage of participants
Interval 14.7 to 49.4
|
19.4 Percentage of participants
Interval 7.5 to 37.5
|
41.4 Percentage of participants
Interval 23.5 to 61.1
|
12.5 Percentage of participants
Interval 3.5 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)
B/Phuket
|
0 Percentage of participants
Interval 0.0 to 10.9
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
0 Percentage of participants
Interval 0.0 to 11.2
|
13.8 Percentage of participants
Interval 3.9 to 31.7
|
12.5 Percentage of participants
Interval 3.5 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)
B/Austria
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
6.3 Percentage of participants
Interval 0.8 to 20.8
|
6.3 Percentage of participants
Interval 0.8 to 20.8
|
6.5 Percentage of participants
Interval 0.8 to 21.4
|
6.9 Percentage of participants
Interval 0.8 to 22.8
|
15.6 Percentage of participants
Interval 5.3 to 32.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination and at 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Percentage of participants with HAI titer \>=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: Before Vaccination
|
53.6 Percentage of participants
Interval 33.9 to 72.5
|
25.9 Percentage of participants
Interval 11.1 to 46.3
|
46.4 Percentage of participants
Interval 27.5 to 66.1
|
44.8 Percentage of participants
Interval 26.4 to 64.3
|
32.1 Percentage of participants
Interval 15.9 to 52.4
|
58.1 Percentage of participants
Interval 39.1 to 75.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: 4 Weeks After Vaccination
|
96.4 Percentage of participants
Interval 81.7 to 99.9
|
92.6 Percentage of participants
Interval 75.7 to 99.1
|
92.9 Percentage of participants
Interval 76.5 to 99.1
|
96.7 Percentage of participants
Interval 82.8 to 99.9
|
100.0 Percentage of participants
Interval 87.7 to 100.0
|
96.8 Percentage of participants
Interval 83.3 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: Before Vaccination
|
60.7 Percentage of participants
Interval 40.6 to 78.5
|
56.0 Percentage of participants
Interval 34.9 to 75.6
|
66.7 Percentage of participants
Interval 46.0 to 83.5
|
51.7 Percentage of participants
Interval 32.5 to 70.6
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
67.7 Percentage of participants
Interval 48.6 to 83.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: 4 Weeks After Vaccination
|
85.2 Percentage of participants
Interval 66.3 to 95.8
|
92.6 Percentage of participants
Interval 75.7 to 99.1
|
96.4 Percentage of participants
Interval 81.7 to 99.9
|
96.7 Percentage of participants
Interval 82.8 to 99.9
|
85.7 Percentage of participants
Interval 67.3 to 96.0
|
87.1 Percentage of participants
Interval 70.2 to 96.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: Before Vaccination
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
25.9 Percentage of participants
Interval 11.1 to 46.3
|
17.9 Percentage of participants
Interval 6.1 to 36.9
|
13.8 Percentage of participants
Interval 3.9 to 31.7
|
21.4 Percentage of participants
Interval 8.3 to 41.0
|
22.6 Percentage of participants
Interval 9.6 to 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: 4 Weeks After Vaccination
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
33.3 Percentage of participants
Interval 16.5 to 54.0
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
33.3 Percentage of participants
Interval 17.3 to 52.8
|
39.3 Percentage of participants
Interval 21.5 to 59.4
|
54.8 Percentage of participants
Interval 36.0 to 72.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: Before Vaccination
|
32.1 Percentage of participants
Interval 15.9 to 52.4
|
25.9 Percentage of participants
Interval 11.1 to 46.3
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
48.3 Percentage of participants
Interval 29.4 to 67.5
|
21.4 Percentage of participants
Interval 8.3 to 41.0
|
51.6 Percentage of participants
Interval 33.1 to 69.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: 4 Weeks After Vaccination
|
57.1 Percentage of participants
Interval 37.2 to 75.5
|
55.6 Percentage of participants
Interval 35.3 to 74.5
|
53.6 Percentage of participants
Interval 33.9 to 72.5
|
70.0 Percentage of participants
Interval 50.6 to 85.3
|
67.9 Percentage of participants
Interval 47.6 to 84.1
|
90.3 Percentage of participants
Interval 74.2 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination and at 4 Weeks After VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Percentage of participants with HAI titer \>=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Wisconsin: Before Vaccination
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
59.4 Percentage of participants
Interval 40.6 to 76.3
|
62.5 Percentage of participants
Interval 43.7 to 78.9
|
71.0 Percentage of participants
Interval 52.0 to 85.8
|
75.9 Percentage of participants
Interval 56.5 to 89.7
|
75.0 Percentage of participants
Interval 56.6 to 88.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Wisconsin: 4 Weeks After Vaccination
|
90.6 Percentage of participants
Interval 75.0 to 98.0
|
96.9 Percentage of participants
Interval 83.8 to 99.9
|
87.5 Percentage of participants
Interval 71.0 to 96.5
|
93.5 Percentage of participants
Interval 78.6 to 99.2
|
93.1 Percentage of participants
Interval 77.2 to 99.2
|
93.8 Percentage of participants
Interval 79.2 to 99.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Austria: 4 Weeks After Vaccination
|
75.0 Percentage of participants
Interval 56.6 to 88.5
|
62.5 Percentage of participants
Interval 43.7 to 78.9
|
65.6 Percentage of participants
Interval 46.8 to 81.4
|
64.5 Percentage of participants
Interval 45.4 to 80.8
|
75.9 Percentage of participants
Interval 56.5 to 89.7
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Darwin: Before Vaccination
|
83.9 Percentage of participants
Interval 66.3 to 94.5
|
81.3 Percentage of participants
Interval 63.6 to 92.8
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
74.2 Percentage of participants
Interval 55.4 to 88.1
|
89.7 Percentage of participants
Interval 72.6 to 97.8
|
78.1 Percentage of participants
Interval 60.0 to 90.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
A/Darwin: 4 Weeks After Vaccination
|
93.8 Percentage of participants
Interval 79.2 to 99.2
|
100.0 Percentage of participants
Interval 89.1 to 100.0
|
96.9 Percentage of participants
Interval 83.8 to 99.9
|
87.1 Percentage of participants
Interval 70.2 to 96.4
|
100.0 Percentage of participants
Interval 88.1 to 100.0
|
90.6 Percentage of participants
Interval 75.0 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Austria: Before Vaccination
|
62.5 Percentage of participants
Interval 43.7 to 78.9
|
56.3 Percentage of participants
Interval 37.7 to 73.6
|
53.1 Percentage of participants
Interval 34.7 to 70.9
|
54.8 Percentage of participants
Interval 36.0 to 72.7
|
62.1 Percentage of participants
Interval 42.3 to 79.3
|
43.8 Percentage of participants
Interval 26.4 to 62.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Phuket: Before Vaccination
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
15.6 Percentage of participants
Interval 5.3 to 32.8
|
15.6 Percentage of participants
Interval 5.3 to 32.8
|
9.7 Percentage of participants
Interval 2.0 to 25.8
|
31.0 Percentage of participants
Interval 15.3 to 50.8
|
12.5 Percentage of participants
Interval 3.5 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
B/Phuket: 4 Weeks After Vaccination
|
31.3 Percentage of participants
Interval 16.1 to 50.0
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
31.3 Percentage of participants
Interval 16.1 to 50.0
|
25.8 Percentage of participants
Interval 11.9 to 44.6
|
51.7 Percentage of participants
Interval 32.5 to 70.6
|
31.3 Percentage of participants
Interval 16.1 to 50.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=25 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years)
|
3.7 Percentage of participants
Interval 0.1 to 19.0
|
0 Percentage of participants
Interval 0.0 to 13.7
|
7.4 Percentage of participants
Interval 0.9 to 24.3
|
3.4 Percentage of participants
Interval 0.1 to 17.8
|
10.7 Percentage of participants
Interval 2.3 to 28.2
|
6.5 Percentage of participants
Interval 0.8 to 21.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=31 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years)
|
0 Percentage of participants
Interval 0.0 to 11.2
|
0 Percentage of participants
Interval 0.0 to 10.9
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.2
|
3.4 Percentage of participants
Interval 0.1 to 17.8
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Percentage of participants achieving HAI titers \>= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=28 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=31 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years)
|
18.5 Percentage of participants
Interval 6.3 to 38.1
|
22.2 Percentage of participants
Interval 8.6 to 42.3
|
21.4 Percentage of participants
Interval 8.3 to 41.0
|
26.7 Percentage of participants
Interval 12.3 to 45.9
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
51.6 Percentage of participants
Interval 33.1 to 69.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.
Percentage of participants achieving HAI titers \>= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=29 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years)
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
15.6 Percentage of participants
Interval 5.3 to 32.8
|
28.1 Percentage of participants
Interval 13.7 to 46.7
|
22.6 Percentage of participants
Interval 9.6 to 41.1
|
41.4 Percentage of participants
Interval 23.5 to 61.1
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination and 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original \[ancestral strain: Wuhan-Hu-1; USA-WA1/2020\]) neutralizing titers before study vaccination and at 4 week after vaccination were reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination
|
3676.8 Titers
Interval 2660.6 to 5081.2
|
2202.4 Titers
Interval 1475.1 to 3288.4
|
2139.4 Titers
Interval 1483.5 to 3085.3
|
3890.4 Titers
Interval 2424.0 to 6243.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
SARS-CoV-2-Reference-Strain Neutralizing Titers: Before Vaccination
|
3068.0 Titers
Interval 2056.4 to 4577.1
|
1466.1 Titers
Interval 869.2 to 2473.0
|
2487.1 Titers
Interval 1541.8 to 4012.0
|
2719.1 Titers
Interval 1828.8 to 4042.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
SARS-CoV-2-Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination
|
12713.5 Titers
Interval 9538.2 to 16945.9
|
8069.0 Titers
Interval 5808.1 to 11209.9
|
7166.0 Titers
Interval 5568.6 to 9221.6
|
10719.9 Titers
Interval 7287.6 to 15768.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination
|
499.0 Titers
Interval 298.2 to 835.0
|
240.9 Titers
Interval 134.6 to 431.3
|
466.9 Titers
Interval 277.8 to 784.7
|
415.8 Titers
Interval 252.0 to 686.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination and 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original \[ancestral strain: Wuhan-Hu-1; USA-WA1/2020\]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination
|
1233.2 Titers
Interval 635.1 to 2394.5
|
678.7 Titers
Interval 347.6 to 1325.1
|
866.0 Titers
Interval 434.5 to 1726.0
|
1472.6 Titers
Interval 742.6 to 2920.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination
|
3627.4 Titers
Interval 2167.0 to 6071.8
|
1841.1 Titers
Interval 1113.0 to 3045.6
|
2770.7 Titers
Interval 1483.7 to 5174.3
|
3774.4 Titers
Interval 2434.8 to 5851.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
Reference-Strain Neutralizing Titers: Before Vaccination
|
6045.7 Titers
Interval 3580.2 to 10209.0
|
4567.0 Titers
Interval 2725.1 to 7654.1
|
4461.1 Titers
Interval 2766.5 to 7193.9
|
7654.1 Titers
Interval 5009.9 to 11693.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination
|
15305.0 Titers
Interval 10000.4 to 23423.4
|
7821.2 Titers
Interval 5348.8 to 11436.4
|
10280.2 Titers
Interval 6847.9 to 15432.9
|
15646.0 Titers
Interval 11782.3 to 20776.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination to 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original \[ancestral strain: Wuhan-Hu-1; USA-WA1/2020\]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
Reference-Strain Neutralizing Titers
|
4.1 Fold Rise
Interval 3.0 to 5.8
|
5.5 Fold Rise
Interval 3.8 to 7.9
|
2.9 Fold Rise
Interval 1.9 to 4.5
|
3.9 Fold Rise
Interval 2.8 to 5.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers
|
7.0 Fold Rise
Interval 4.7 to 10.4
|
7.6 Fold Rise
Interval 5.8 to 10.0
|
4.4 Fold Rise
Interval 2.7 to 7.1
|
8.7 Fold Rise
Interval 5.6 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination to 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original \[ancestral strain: Wuhan-Hu-1; USA-WA1/2020\]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
Reference-Strain Neutralizing Titers
|
2.5 Fold Rise
Interval 1.9 to 3.4
|
1.7 Fold Rise
Interval 1.3 to 2.3
|
2.3 Fold Rise
Interval 1.8 to 3.0
|
2.0 Fold Rise
Interval 1.5 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers
|
2.8 Fold Rise
Interval 2.0 to 3.9
|
2.4 Fold Rise
Interval 1.8 to 3.3
|
3.0 Fold Rise
Interval 2.2 to 4.2
|
2.4 Fold Rise
Interval 1.7 to 3.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of \>= 4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=27 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=31 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers
|
67.9 Percentage of participants
Interval 47.6 to 84.1
|
85.2 Percentage of participants
Interval 66.3 to 95.8
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
74.2 Percentage of participants
Interval 55.4 to 88.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Reference-Strain Neutralizing Titers
|
46.4 Percentage of participants
Interval 27.5 to 66.1
|
63.0 Percentage of participants
Interval 42.4 to 80.6
|
32.1 Percentage of participants
Interval 15.9 to 52.4
|
48.4 Percentage of participants
Interval 30.2 to 66.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSA:4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of \>= 4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (>=65 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers
|
34.4 Percentage of participants
Interval 18.6 to 53.2
|
28.1 Percentage of participants
Interval 13.7 to 46.7
|
35.5 Percentage of participants
Interval 19.2 to 54.6
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (>=65 Years)
Reference-Strain Neutralizing Titers
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
15.6 Percentage of participants
Interval 5.3 to 32.8
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
18.8 Percentage of participants
Interval 7.2 to 36.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SSB: Before Vaccination and 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=122 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=118 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=109 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=28 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=30 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=25 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: Before vaccination
|
51.2 Titers
Interval 27.2 to 96.6
|
44.6 Titers
Interval 26.4 to 75.3
|
44.4 Titers
Interval 35.0 to 56.2
|
53.3 Titers
Interval 41.1 to 69.2
|
53.5 Titers
Interval 41.9 to 68.4
|
46.4 Titers
Interval 30.4 to 70.8
|
55.1 Titers
Interval 33.3 to 91.0
|
51.9 Titers
Interval 33.2 to 81.2
|
45.3 Titers
Interval 29.9 to 68.5
|
31.5 Titers
Interval 17.8 to 55.7
|
46.2 Titers
Interval 26.6 to 80.2
|
37.8 Titers
Interval 21.2 to 67.4
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: 4 Weeks after vaccination
|
181.1 Titers
Interval 114.0 to 287.7
|
343.9 Titers
Interval 232.1 to 509.5
|
213.4 Titers
Interval 171.8 to 265.1
|
277.3 Titers
Interval 228.1 to 337.1
|
215.8 Titers
Interval 175.0 to 266.3
|
217.1 Titers
Interval 137.2 to 343.4
|
155.8 Titers
Interval 98.5 to 246.3
|
149.9 Titers
Interval 103.3 to 217.5
|
120.1 Titers
Interval 87.3 to 165.3
|
139.3 Titers
Interval 90.7 to 213.9
|
173.2 Titers
Interval 112.6 to 266.4
|
178.8 Titers
Interval 114.0 to 280.4
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: Before vaccination
|
33.7 Titers
Interval 18.5 to 61.4
|
35.1 Titers
Interval 23.0 to 53.6
|
22.6 Titers
Interval 18.8 to 27.1
|
36.2 Titers
Interval 29.3 to 44.7
|
31.3 Titers
Interval 25.9 to 38.0
|
51.7 Titers
Interval 32.5 to 82.2
|
62.9 Titers
Interval 41.7 to 94.9
|
31.5 Titers
Interval 22.1 to 45.0
|
38.1 Titers
Interval 26.4 to 54.8
|
18.4 Titers
Interval 11.3 to 30.1
|
26.9 Titers
Interval 16.2 to 44.8
|
18.9 Titers
Interval 11.9 to 30.2
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: 4 Weeks after vaccination
|
82.1 Titers
Interval 51.9 to 129.9
|
172.3 Titers
Interval 126.4 to 235.0
|
110.0 Titers
Interval 90.4 to 134.0
|
173.4 Titers
Interval 142.9 to 210.3
|
149.6 Titers
Interval 121.6 to 184.1
|
172.3 Titers
Interval 112.3 to 264.6
|
125.9 Titers
Interval 88.4 to 179.3
|
110.7 Titers
Interval 83.4 to 147.0
|
106.6 Titers
Interval 80.0 to 141.9
|
80.0 Titers
Interval 52.9 to 120.9
|
141.4 Titers
Interval 96.0 to 208.3
|
99.9 Titers
Interval 68.6 to 145.4
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: Before vaccination
|
21.0 Titers
Interval 11.6 to 38.1
|
13.3 Titers
Interval 8.5 to 20.6
|
17.3 Titers
Interval 13.9 to 21.6
|
19.2 Titers
Interval 15.3 to 24.1
|
20.1 Titers
Interval 15.9 to 25.4
|
14.9 Titers
Interval 9.7 to 22.7
|
33.2 Titers
Interval 19.7 to 56.0
|
12.2 Titers
Interval 8.4 to 17.6
|
20.0 Titers
Interval 13.1 to 30.5
|
12.7 Titers
Interval 8.4 to 19.3
|
16.9 Titers
Interval 10.8 to 26.5
|
16.0 Titers
Interval 9.4 to 27.3
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: 4 Weeks after vaccination
|
36.2 Titers
Interval 22.7 to 57.8
|
37.4 Titers
Interval 24.7 to 56.8
|
32.2 Titers
Interval 25.9 to 40.0
|
33.1 Titers
Interval 26.6 to 41.3
|
30.7 Titers
Interval 24.6 to 38.3
|
26.9 Titers
Interval 16.9 to 42.9
|
66.4 Titers
Interval 43.5 to 101.4
|
22.3 Titers
Interval 15.1 to 32.8
|
28.6 Titers
Interval 19.5 to 42.0
|
23.5 Titers
Interval 15.4 to 35.8
|
36.4 Titers
Interval 23.1 to 57.3
|
27.1 Titers
Interval 16.5 to 44.6
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: Before vaccination
|
35.3 Titers
Interval 24.3 to 51.3
|
26.5 Titers
Interval 17.2 to 40.9
|
24.0 Titers
Interval 19.7 to 29.3
|
25.3 Titers
Interval 20.9 to 30.6
|
25.6 Titers
Interval 21.1 to 31.2
|
18.6 Titers
Interval 12.4 to 27.8
|
20.0 Titers
Interval 13.1 to 30.6
|
23.3 Titers
Interval 15.3 to 35.4
|
15.0 Titers
Interval 10.4 to 21.6
|
—
|
—
|
18.4 Titers
Interval 12.1 to 27.9
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: 4 Weeks after vaccination
|
52.5 Titers
Interval 36.6 to 75.3
|
49.7 Titers
Interval 32.1 to 76.9
|
44.3 Titers
Interval 36.0 to 54.7
|
48.0 Titers
Interval 40.0 to 57.6
|
46.2 Titers
Interval 38.6 to 55.3
|
27.6 Titers
Interval 18.8 to 40.5
|
36.0 Titers
Interval 22.1 to 58.5
|
46.5 Titers
Interval 32.6 to 66.6
|
23.1 Titers
Interval 15.6 to 34.3
|
—
|
—
|
38.9 Titers
Interval 24.7 to 61.1
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Cambodia: Before vaccination
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.1 Titers
Interval 8.3 to 20.4
|
—
|
27.2 Titers
Interval 15.8 to 46.9
|
|
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Cambodia: 4 Weeks after vaccination
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
60.6 Titers
Interval 40.5 to 90.9
|
—
|
77.7 Titers
Interval 60.5 to 99.9
|
SECONDARY outcome
Timeframe: SSB: Before Vaccination to 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=122 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=118 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=109 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=28 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=30 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=25 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin
|
3.1 Fold Rise
Interval 1.9 to 5.3
|
6.9 Fold Rise
Interval 4.1 to 11.7
|
4.5 Fold Rise
Interval 3.7 to 5.5
|
4.8 Fold Rise
Interval 3.8 to 5.9
|
3.8 Fold Rise
Interval 3.1 to 4.7
|
4.5 Fold Rise
Interval 2.8 to 7.1
|
2.8 Fold Rise
Interval 1.8 to 4.3
|
2.7 Fold Rise
Interval 2.1 to 3.4
|
2.4 Fold Rise
Interval 1.7 to 3.6
|
3.6 Fold Rise
Interval 2.3 to 5.5
|
3.5 Fold Rise
Interval 2.4 to 5.1
|
4.0 Fold Rise
Interval 3.0 to 5.4
|
|
SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
A/Darwin
|
2.3 Fold Rise
Interval 1.4 to 3.7
|
4.2 Fold Rise
Interval 2.9 to 6.1
|
4.4 Fold Rise
Interval 3.7 to 5.2
|
4.4 Fold Rise
Interval 3.6 to 5.3
|
4.4 Fold Rise
Interval 3.6 to 5.4
|
3.5 Fold Rise
Interval 2.3 to 5.4
|
1.9 Fold Rise
Interval 1.4 to 2.8
|
3.3 Fold Rise
Interval 2.5 to 4.4
|
2.8 Fold Rise
Interval 2.0 to 4.1
|
3.3 Fold Rise
Interval 2.4 to 4.4
|
4.7 Fold Rise
Interval 3.3 to 6.5
|
4.3 Fold Rise
Interval 3.1 to 6.0
|
|
SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
B/Austria
|
1.3 Fold Rise
Interval 1.0 to 1.8
|
2.2 Fold Rise
Interval 1.6 to 3.0
|
1.6 Fold Rise
Interval 1.4 to 1.8
|
1.5 Fold Rise
Interval 1.4 to 1.7
|
1.4 Fold Rise
Interval 1.3 to 1.6
|
1.6 Fold Rise
Interval 1.3 to 2.0
|
1.8 Fold Rise
Interval 1.4 to 2.5
|
1.6 Fold Rise
Interval 1.3 to 2.0
|
1.3 Fold Rise
Interval 1.0 to 1.6
|
1.6 Fold Rise
Interval 1.3 to 2.0
|
1.9 Fold Rise
Interval 1.4 to 2.6
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
|
SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
B/Phuket
|
1.4 Fold Rise
Interval 1.1 to 1.9
|
1.8 Fold Rise
Interval 1.3 to 2.4
|
1.7 Fold Rise
Interval 1.5 to 1.9
|
1.8 Fold Rise
Interval 1.6 to 2.0
|
1.7 Fold Rise
Interval 1.5 to 2.0
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.7 Fold Rise
Interval 1.4 to 2.1
|
1.7 Fold Rise
Interval 1.5 to 2.0
|
1.4 Fold Rise
Interval 1.1 to 1.7
|
—
|
—
|
1.8 Fold Rise
Interval 1.5 to 2.3
|
|
SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
A/Cambodia
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.5 Fold Rise
Interval 2.5 to 4.9
|
—
|
2.4 Fold Rise
Interval 1.8 to 3.2
|
SECONDARY outcome
Timeframe: SSB: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations."Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. And 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria,
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=121 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=118 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=107 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=28 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=29 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=25 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin
|
40.7 Percentage of participants
Interval 22.4 to 61.2
|
61.3 Percentage of participants
Interval 42.2 to 78.2
|
64.5 Percentage of participants
Interval 55.2 to 73.0
|
64.4 Percentage of participants
Interval 55.1 to 73.0
|
64.5 Percentage of participants
Interval 54.6 to 73.5
|
59.3 Percentage of participants
Interval 38.8 to 77.6
|
19.2 Percentage of participants
Interval 6.6 to 39.4
|
56.3 Percentage of participants
Interval 37.7 to 73.6
|
39.3 Percentage of participants
Interval 21.5 to 59.4
|
50.0 Percentage of participants
Interval 29.1 to 70.9
|
70.4 Percentage of participants
Interval 49.8 to 86.2
|
64.0 Percentage of participants
Interval 42.5 to 82.0
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
65.6 Percentage of participants
Interval 46.8 to 81.4
|
64.2 Percentage of participants
Interval 54.9 to 72.7
|
62.7 Percentage of participants
Interval 53.3 to 71.4
|
56.1 Percentage of participants
Interval 46.1 to 65.7
|
64.3 Percentage of participants
Interval 44.1 to 81.4
|
34.6 Percentage of participants
Interval 17.2 to 55.7
|
34.4 Percentage of participants
Interval 18.6 to 53.2
|
25.0 Percentage of participants
Interval 10.7 to 44.9
|
40.0 Percentage of participants
Interval 21.1 to 61.3
|
44.8 Percentage of participants
Interval 26.4 to 64.3
|
68.0 Percentage of participants
Interval 46.5 to 85.1
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
A/Cambodia
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
60.0 Percentage of participants
Interval 38.7 to 78.9
|
—
|
35.3 Percentage of participants
Interval 14.2 to 61.7
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
B/Austria
|
17.9 Percentage of participants
Interval 6.1 to 36.9
|
25.8 Percentage of participants
Interval 11.9 to 44.6
|
16.5 Percentage of participants
Interval 10.4 to 24.4
|
12.7 Percentage of participants
Interval 7.3 to 20.1
|
9.3 Percentage of participants
Interval 4.6 to 16.5
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
23.1 Percentage of participants
Interval 9.0 to 43.6
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
10.3 Percentage of participants
Interval 2.2 to 27.4
|
15.4 Percentage of participants
Interval 4.4 to 34.9
|
20.7 Percentage of participants
Interval 8.0 to 39.7
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket
|
7.1 Percentage of participants
Interval 0.9 to 23.5
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
14.9 Percentage of participants
Interval 9.1 to 22.5
|
18.6 Percentage of participants
Interval 12.1 to 26.9
|
14.2 Percentage of participants
Interval 8.1 to 22.3
|
7.1 Percentage of participants
Interval 0.9 to 23.5
|
11.5 Percentage of participants
Interval 2.4 to 30.2
|
6.3 Percentage of participants
Interval 0.8 to 20.8
|
13.8 Percentage of participants
Interval 3.9 to 31.7
|
—
|
—
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
SECONDARY outcome
Timeframe: SSB: Before Vaccination and at 4 Weeks after VaccinationPopulation: EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Percentage of participants with HAI titer \>=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=121 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=118 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=108 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=28 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=29 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=25 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: Before Vaccination
|
64.3 Percentage of participants
Interval 44.1 to 81.4
|
65.6 Percentage of participants
Interval 46.8 to 81.4
|
64.2 Percentage of participants
Interval 54.9 to 72.7
|
69.5 Percentage of participants
Interval 60.3 to 77.6
|
71.0 Percentage of participants
Interval 61.5 to 79.4
|
71.4 Percentage of participants
Interval 51.3 to 86.8
|
61.5 Percentage of participants
Interval 40.6 to 79.8
|
78.1 Percentage of participants
Interval 60.0 to 90.7
|
71.4 Percentage of participants
Interval 51.3 to 86.8
|
50.0 Percentage of participants
Interval 29.9 to 70.1
|
65.5 Percentage of participants
Interval 45.7 to 82.1
|
64.0 Percentage of participants
Interval 42.5 to 82.0
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Wisconsin: 4 weeks after vaccination
|
92.9 Percentage of participants
Interval 76.5 to 99.1
|
100.0 Percentage of participants
Interval 89.1 to 100.0
|
95.0 Percentage of participants
Interval 89.5 to 98.2
|
99.2 Percentage of participants
Interval 95.4 to 100.0
|
97.2 Percentage of participants
Interval 92.1 to 99.4
|
96.4 Percentage of participants
Interval 81.7 to 99.9
|
96.2 Percentage of participants
Interval 80.4 to 99.9
|
93.8 Percentage of participants
Interval 79.2 to 99.2
|
96.6 Percentage of participants
Interval 82.2 to 99.9
|
88.0 Percentage of participants
Interval 68.8 to 97.5
|
89.7 Percentage of participants
Interval 72.6 to 97.8
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: Before Vaccination
|
40.7 Percentage of participants
Interval 22.4 to 61.2
|
62.5 Percentage of participants
Interval 43.7 to 78.9
|
45.5 Percentage of participants
Interval 36.4 to 54.8
|
64.4 Percentage of participants
Interval 55.1 to 73.0
|
61.1 Percentage of participants
Interval 51.3 to 70.3
|
74.1 Percentage of participants
Interval 53.7 to 88.9
|
84.6 Percentage of participants
Interval 65.1 to 95.6
|
56.3 Percentage of participants
Interval 37.7 to 73.6
|
67.9 Percentage of participants
Interval 47.6 to 84.1
|
44.0 Percentage of participants
Interval 24.4 to 65.1
|
46.4 Percentage of participants
Interval 27.5 to 66.1
|
44.0 Percentage of participants
Interval 24.4 to 65.1
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Darwin: 4 weeks after vaccination
|
81.5 Percentage of participants
Interval 61.9 to 93.7
|
100.0 Percentage of participants
Interval 88.8 to 100.0
|
92.6 Percentage of participants
Interval 86.3 to 96.5
|
96.6 Percentage of participants
Interval 91.5 to 99.1
|
95.3 Percentage of participants
Interval 89.4 to 98.5
|
92.9 Percentage of participants
Interval 76.5 to 99.1
|
96.2 Percentage of participants
Interval 80.4 to 99.9
|
96.9 Percentage of participants
Interval 83.8 to 99.9
|
96.6 Percentage of participants
Interval 82.2 to 99.9
|
88.0 Percentage of participants
Interval 68.8 to 97.5
|
92.9 Percentage of participants
Interval 76.5 to 99.1
|
88.0 Percentage of participants
Interval 68.8 to 97.5
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Cambodia: Before Vaccination
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
30.8 Percentage of participants
Interval 14.3 to 51.8
|
—
|
61.1 Percentage of participants
Interval 35.7 to 82.7
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
A/Cambodia: 4 weeks after vaccination
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
88.0 Percentage of participants
Interval 68.8 to 97.5
|
—
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: Before Vaccination
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
30.6 Percentage of participants
Interval 22.5 to 39.6
|
33.9 Percentage of participants
Interval 25.4 to 43.2
|
32.4 Percentage of participants
Interval 23.7 to 42.1
|
39.3 Percentage of participants
Interval 21.5 to 59.4
|
50.0 Percentage of participants
Interval 29.9 to 70.1
|
15.6 Percentage of participants
Interval 5.3 to 32.8
|
41.4 Percentage of participants
Interval 23.5 to 61.1
|
19.2 Percentage of participants
Interval 6.6 to 39.4
|
31.0 Percentage of participants
Interval 15.3 to 50.8
|
36.0 Percentage of participants
Interval 18.0 to 57.5
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Austria: 4 weeks after vaccination
|
53.6 Percentage of participants
Interval 33.9 to 72.5
|
58.1 Percentage of participants
Interval 39.1 to 75.5
|
55.4 Percentage of participants
Interval 46.1 to 64.4
|
53.4 Percentage of participants
Interval 44.0 to 62.6
|
52.3 Percentage of participants
Interval 42.5 to 62.1
|
53.6 Percentage of participants
Interval 33.9 to 72.5
|
80.8 Percentage of participants
Interval 60.6 to 93.4
|
40.6 Percentage of participants
Interval 23.7 to 59.4
|
55.2 Percentage of participants
Interval 35.7 to 73.6
|
34.6 Percentage of participants
Interval 17.2 to 55.7
|
58.6 Percentage of participants
Interval 38.9 to 76.5
|
48.0 Percentage of participants
Interval 27.8 to 68.7
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: Before Vaccination
|
60.7 Percentage of participants
Interval 40.6 to 78.5
|
43.8 Percentage of participants
Interval 26.4 to 62.3
|
44.6 Percentage of participants
Interval 35.6 to 53.9
|
45.8 Percentage of participants
Interval 36.6 to 55.2
|
43.4 Percentage of participants
Interval 33.8 to 53.4
|
39.3 Percentage of participants
Interval 21.5 to 59.4
|
34.6 Percentage of participants
Interval 17.2 to 55.7
|
50.0 Percentage of participants
Interval 31.9 to 68.1
|
31.0 Percentage of participants
Interval 15.3 to 50.8
|
—
|
—
|
44.0 Percentage of participants
Interval 24.4 to 65.1
|
|
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
B/Phuket: 4 weeks after vaccination
|
78.6 Percentage of participants
Interval 59.0 to 91.7
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
61.2 Percentage of participants
Interval 51.9 to 69.9
|
72.0 Percentage of participants
Interval 63.0 to 79.9
|
70.8 Percentage of participants
Interval 61.1 to 79.2
|
50.0 Percentage of participants
Interval 30.6 to 69.4
|
53.8 Percentage of participants
Interval 33.4 to 73.4
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
41.4 Percentage of participants
Interval 23.5 to 61.1
|
—
|
—
|
58.3 Percentage of participants
Interval 36.6 to 77.9
|
SECONDARY outcome
Timeframe: SSB: Before Vaccination and at 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within specified time frame after vaccination;had at least 1 valid \& determinate assay result at 4-week post-vaccination visit \& had no major protocol deviations."Number of Participants Analyzed" =participants evaluable \& 'Number Analyzed' = participants evaluable for specified rows. Only arms which received covid vaccine (BNT162b2) were analyzed.
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original \[ancestral strain: Wuhan-Hu-1; USA-WA1/2020\]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=122 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=118 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=109 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=28 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=30 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination
|
8132.5 Titers
Interval 5096.4 to 12977.5
|
7499.8 Titers
Interval 5006.7 to 11234.3
|
10769.8 Titers
Interval 8913.3 to 13013.1
|
10818.7 Titers
Interval 9168.3 to 12766.1
|
12081.5 Titers
Interval 9913.1 to 14724.1
|
11319.8 Titers
Interval 8175.0 to 15674.2
|
9991.0 Titers
Interval 5806.7 to 17190.6
|
11632.2 Titers
Interval 8796.5 to 15382.0
|
14921.6 Titers
Interval 10784.9 to 20645.0
|
10981.2 Titers
Interval 8062.1 to 14957.2
|
14605.4 Titers
Interval 9717.6 to 21951.8
|
—
|
|
SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Reference-Strain Neutralizing Titers: Before Vaccination
|
3396.1 Titers
Interval 1798.7 to 6412.1
|
3569.4 Titers
Interval 2078.0 to 6131.0
|
4128.9 Titers
Interval 3186.9 to 5349.3
|
4335.7 Titers
Interval 3490.1 to 5386.1
|
4260.5 Titers
Interval 3401.1 to 5337.0
|
4846.4 Titers
Interval 3179.9 to 7386.1
|
5693.9 Titers
Interval 3566.5 to 9090.3
|
4255.8 Titers
Interval 2915.9 to 6211.3
|
4840.6 Titers
Interval 3256.3 to 7195.8
|
5380.6 Titers
Interval 3260.2 to 8880.2
|
3678.1 Titers
Interval 2256.0 to 5996.7
|
—
|
|
SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination
|
989.5 Titers
Interval 524.6 to 1866.2
|
1081.4 Titers
Interval 622.6 to 1878.2
|
1127.6 Titers
Interval 827.8 to 1535.9
|
1289.6 Titers
Interval 997.2 to 1667.7
|
1361.4 Titers
Interval 1041.5 to 1779.5
|
1805.5 Titers
Interval 1021.6 to 3191.0
|
1527.8 Titers
Interval 870.8 to 2680.3
|
1343.6 Titers
Interval 887.6 to 2033.9
|
1207.8 Titers
Interval 694.2 to 2101.3
|
1688.9 Titers
Interval 1064.0 to 2680.7
|
1054.2 Titers
Interval 576.3 to 1928.4
|
—
|
|
SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination
|
4353.8 Titers
Interval 2783.5 to 6810.1
|
2960.9 Titers
Interval 1867.0 to 4695.9
|
3606.3 Titers
Interval 2902.8 to 4480.3
|
3555.6 Titers
Interval 2901.5 to 4357.2
|
3997.9 Titers
Interval 3197.4 to 4998.8
|
4131.7 Titers
Interval 2663.8 to 6408.6
|
3878.7 Titers
Interval 2431.9 to 6186.4
|
3999.6 Titers
Interval 2780.1 to 5753.9
|
6018.8 Titers
Interval 4347.5 to 8332.4
|
4659.7 Titers
Interval 3181.4 to 6825.0
|
4385.7 Titers
Interval 2546.4 to 7553.6
|
—
|
SECONDARY outcome
Timeframe: SSB: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within specified time frame after vaccination;had at least 1 valid \& determinate assay result at 4-week post-vaccination visit \& had no major protocol deviations."Number of Participants Analyzed" =participants evaluable \& 'Number Analyzed' = participants evaluable for specified rows. Only arms which received covid vaccine (BNT162b2) were analyzed.
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original \[ancestral strain: Wuhan-Hu-1; USA-WA1/2020\]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=122 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=118 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=109 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=28 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=30 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers
|
4.1 Fold rise
Interval 2.4 to 6.9
|
2.7 Fold rise
Interval 1.6 to 4.5
|
3.0 Fold rise
Interval 2.5 to 3.7
|
2.6 Fold rise
Interval 2.2 to 3.2
|
2.8 Fold rise
Interval 2.3 to 3.5
|
2.6 Fold rise
Interval 1.8 to 3.7
|
2.5 Fold rise
Interval 1.6 to 3.8
|
2.9 Fold rise
Interval 2.2 to 3.8
|
4.6 Fold rise
Interval 3.0 to 7.0
|
2.8 Fold rise
Interval 1.9 to 4.0
|
3.7 Fold rise
Interval 2.6 to 5.3
|
—
|
|
SSB: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
Reference-Strain Neutralizing Titers
|
2.4 Fold rise
Interval 1.5 to 3.8
|
2.1 Fold rise
Interval 1.4 to 3.1
|
2.6 Fold rise
Interval 2.2 to 3.1
|
2.5 Fold rise
Interval 2.1 to 3.0
|
2.8 Fold rise
Interval 2.4 to 3.3
|
2.5 Fold rise
Interval 1.9 to 3.3
|
1.8 Fold rise
Interval 1.0 to 3.1
|
2.7 Fold rise
Interval 2.2 to 3.5
|
3.1 Fold rise
Interval 2.1 to 4.5
|
2.0 Fold rise
Interval 1.2 to 3.5
|
3.8 Fold rise
Interval 2.6 to 5.6
|
—
|
SECONDARY outcome
Timeframe: SSB: 4 Weeks after VaccinationPopulation: EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within specified time frame after vaccination;had at least 1 valid \& determinate assay result at 4-week post-vaccination visit \& had no major protocol deviations."Number of Participants Analyzed" =participants evaluable \& 'Number Analyzed' = participants evaluable for specified rows. Only arms which received covid vaccine (BNT162b2) were analyzed.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of \>= 4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
Outcome measures
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=28 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=120 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=117 Participants
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=108 Participants
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=27 Participants
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=32 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=29 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 Participants
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=29 Participants
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Omicron (BA.4/BA.5)- Neutralizing Titers
|
50.0 Percentage of participants
Interval 30.6 to 69.4
|
37.5 Percentage of participants
Interval 21.1 to 56.3
|
35.8 Percentage of participants
Interval 27.3 to 45.1
|
29.9 Percentage of participants
Interval 21.8 to 39.1
|
30.6 Percentage of participants
Interval 22.1 to 40.2
|
38.5 Percentage of participants
Interval 20.2 to 59.4
|
30.8 Percentage of participants
Interval 14.3 to 51.8
|
38.7 Percentage of participants
Interval 21.8 to 57.8
|
46.4 Percentage of participants
Interval 27.5 to 66.1
|
26.9 Percentage of participants
Interval 11.6 to 47.8
|
44.8 Percentage of participants
Interval 26.4 to 64.3
|
—
|
|
SSB: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Reference-Strain Neutralizing Titers
|
33.3 Percentage of participants
Interval 16.5 to 54.0
|
25.8 Percentage of participants
Interval 11.9 to 44.6
|
33.6 Percentage of participants
Interval 25.2 to 42.8
|
30.8 Percentage of participants
Interval 22.6 to 40.0
|
31.5 Percentage of participants
Interval 22.9 to 41.1
|
25.9 Percentage of participants
Interval 11.1 to 46.3
|
23.1 Percentage of participants
Interval 9.0 to 43.6
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
41.4 Percentage of participants
Interval 23.5 to 61.1
|
23.1 Percentage of participants
Interval 9.0 to 43.6
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
—
|
Adverse Events
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Substudy A, 18-64 Years: qIRV 30 mcg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Substudy A, 18-64 Years: qIRV 60 mcg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Substudy A, >=65 Years: qIRV 30 mcg
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Substudy A, >=65 Years: qIRV 60 mcg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Serious events: 0 serious events
Other events: 107 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Serious events: 0 serious events
Other events: 104 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 1)
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Substudy B, 18-64 Years: qIRV (30 mcg)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 participants at risk
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 participants at risk
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 participants at risk
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 participants at risk
Participants aged greater than or equal to (\>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
n=32 participants at risk
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 participants at risk
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 30 mcg
n=33 participants at risk
Participants aged \>=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 60 mcg
n=33 participants at risk
Participants aged \>=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 participants at risk
Participants aged \>=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
n=29 participants at risk
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
n=32 participants at risk
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=124 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=122 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 1)
n=114 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg)
n=31 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 participants at risk
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=29 participants at risk
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.2%
1/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.6%
1/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
Other adverse events
| Measure |
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
n=28 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 30 mcg
n=30 participants at risk
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: qIRV 60 mcg
n=30 participants at risk
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=32 participants at risk
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=33 participants at risk
Participants aged greater than or equal to (\>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
n=32 participants at risk
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=33 participants at risk
Participants aged \>=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 30 mcg
n=33 participants at risk
Participants aged \>=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: qIRV 60 mcg
n=33 participants at risk
Participants aged \>=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
|
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
n=33 participants at risk
Participants aged \>=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
n=29 participants at risk
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
n=32 participants at risk
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
n=124 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
n=122 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 1)
n=114 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg)
n=31 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2)
n=33 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4)
n=30 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3)
n=26 participants at risk
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg)
n=32 participants at risk
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
|
Substudy B, 18-64 Years: qIRV (30 mcg)
n=29 participants at risk
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.6%
1/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.81%
1/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.82%
1/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.2%
1/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Chest pain
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Chills (CHILLS)
|
53.3%
16/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
50.0%
14/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
53.3%
16/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
23.3%
7/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
21.9%
7/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
36.4%
12/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
21.9%
7/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.1%
3/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
30.3%
10/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.1%
4/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.3%
3/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
28.1%
9/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.1%
41/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
38.5%
47/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
38/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
54.8%
17/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
11/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
30.8%
8/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
31.2%
10/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
27.6%
8/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Fatigue (FATIGUE)
|
50.0%
15/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
50.0%
14/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
60.0%
18/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
46.9%
15/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
69.7%
23/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
37.5%
12/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
57.6%
19/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
11/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
54.5%
18/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
11/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
41.4%
12/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
37.5%
12/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
60.5%
75/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
65.6%
80/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
57.0%
65/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
67.7%
21/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
66.7%
20/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
51.5%
17/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
70.0%
21/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
61.5%
16/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
53.1%
17/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
37.9%
11/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Injection site erythema
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Injection site erythema (REDNESS)
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.7%
3/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.0%
3/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.4%
3/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.2%
6/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.2%
2/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
21.2%
7/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.1%
4/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.8%
6/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.5%
13/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.0%
22/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
11.4%
13/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.7%
3/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.7%
2/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
15.4%
4/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.8%
6/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.9%
2/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Injection site pain
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.81%
1/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Injection site pain (PAIN)
|
83.3%
25/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
89.3%
25/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
80.0%
24/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
63.3%
19/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
73.3%
22/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
71.9%
23/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
84.8%
28/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
53.1%
17/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
81.8%
27/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
63.6%
21/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
72.7%
24/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
48.5%
16/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
58.6%
17/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
71.9%
23/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
76.6%
95/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
80.3%
98/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
74.6%
85/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
80.6%
25/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
80.0%
24/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
81.8%
27/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
66.7%
20/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
69.2%
18/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
71.9%
23/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
69.0%
20/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Injection site swelling (SWELLING)
|
16.7%
5/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.6%
1/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.7%
2/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.7%
2/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.4%
3/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.1%
3/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.2%
2/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.1%
4/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.1%
3/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.4%
1/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.2%
2/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.5%
13/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
14.8%
18/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.3%
14/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
19.4%
6/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
11.5%
3/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
25.0%
8/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.9%
2/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
Pyrexia (FEVER)
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.7%
3/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
26.7%
8/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.0%
3/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.4%
3/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.1%
4/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.4%
1/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.2%
2/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.9%
16/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.0%
22/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.6%
11/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
32.3%
10/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.0%
3/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
20.0%
6/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
7.7%
2/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.5%
4/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.3%
3/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.6%
1/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.7%
2/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.2%
2/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.1%
3/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.1%
3/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.9%
2/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.7%
12/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.6%
8/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.6%
11/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.7%
3/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.0%
3/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.2%
6/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.0%
3/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
11.5%
3/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.4%
3/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.9%
2/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
6.7%
2/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.81%
1/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
5.7%
7/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.5%
4/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
7.7%
2/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.2%
2/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.81%
1/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.82%
1/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.88%
1/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.2%
1/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.82%
1/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.88%
1/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
16.7%
5/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
17.9%
5/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
25.0%
8/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.1%
3/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.1%
3/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
15.2%
5/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
10.3%
3/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
9.4%
3/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
27.4%
34/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
23.8%
29/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
24.6%
28/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
19.4%
6/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
21.2%
7/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.3%
4/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
30.8%
8/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
15.6%
5/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.8%
4/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
46.7%
14/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
32.1%
9/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
16.7%
5/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
16.7%
5/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
34.4%
11/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
24.2%
8/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
12.5%
4/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
36.4%
12/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
15.2%
5/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
24.2%
8/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
20.7%
6/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
25.0%
8/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
36.3%
45/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
36.9%
45/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
38/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
54.8%
17/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
23.3%
7/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
11/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
30.8%
8/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
40.6%
13/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
13.8%
4/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.81%
1/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.2%
1/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Nervous system disorders
Headache (HEADACHE)
|
53.3%
16/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
57.1%
16/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
50.0%
15/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
23.3%
7/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
40.0%
12/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
50.0%
16/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
48.5%
16/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.8%
6/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
36.4%
12/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
24.2%
8/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
21.2%
7/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
18.2%
6/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
20.7%
6/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
37.5%
12/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
50.0%
62/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
50.0%
61/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
42.1%
48/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
58.1%
18/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
46.7%
14/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
39.4%
13/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
33.3%
10/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
38.5%
10/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
46.9%
15/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
24.1%
7/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.88%
1/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.6%
1/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.3%
1/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
6.1%
2/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.0%
1/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/28 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
3.1%
1/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/124 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/122 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/114 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/31 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/33 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/30 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/26 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/32 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
0.00%
0/29 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
|
Additional Information
BioNTech clinical trials patient information
BioNTech SE
Phone: +49 6131 90840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor (or its agents) has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER